iRestore Second-Wave Forensic Investigation

# iRestore Second-Wave Forensic Investigation: Hidden Continuities, Sensory-Stack Compression, and Installed-Base Logic ## Prefatory Note This is a second-wave investigation building on an established baseline. It does not re-prove that transcranial PBM exists, that iRestore has 500 diodes, or that Freedom Laser had smoking-cessation origins. It investigates the **overlooked connective tissue**: primary documents, archived clinical protocols, withdrawn features, official trial registrations, SEC filings, corporate genealogy artifacts, and regulatory-creep patterns that materially deepen the thesis. *** ## 1. What's Actually New ### 1.1 The Sensory-Stack Stripping Event: A Primary-Source Confirmed Finding The most forensically significant new finding is **documented directly in FDA primary source K151662** (the 2016 510(k) clearance for the original iRestore).[^1][^2] The submission states, verbatim: *"The iRestore device is IDENTICAL to the device known as the igrow Hair Growth System... There is one ergonomic design distinction between the two systems. The iRestore is not configured with, audio capability through attached ear phones."* The predicate device — Apira Science's iGrow — was explicitly equipped with **built-in headphones, a 2.5mm audio jack, and an iPod/MP3 interface**, allowing users to listen to music or podcasts during their 25-minute treatment sessions. Multiple independent clinical and retail sources confirm this feature was present and marketed as a design benefit.[^3][^4][^5][^6][^7] The iRestore was cleared as substantially equivalent to the iGrow, with the FDA accepting the removal of audio capability as a non-material distinction: *"The lack of ear phones in the iRestore has no significance in the comparative process between the NEW device and the predicate."*[^1] **What this means:** iRestore was not invented fresh. It was designed **from a device that already integrated synchronized audio** with light therapy. That audio layer was explicitly stripped from the product to achieve regulatory clearance through a simplified predicate comparison. This is a primary-source confirmed sensory-stack compression event, not an inference. ### 1.2 The FQS Clinical Trial: Freedom Laser's Own Brain-Receptor Claim in Official Documentation Freedom Laser, Inc. registered a formal clinical trial with ClinicalTrials.gov under **NCT04830384**: *"Evaluation Into the Efficacy of Low Level Laser/Light and Music as a Combined Therapy Device for Smoking Cessation Treatment."*[^8][^9] The trial description states the device — called the FQS system — is *"a type of cold, or non-heat producing laser and tranquil music system that will emit light and music onto the ear surface, through commonly found music earphones."* The theoretical mechanism reads: *"The theory behind this treatment technique is that the light and music will stimulate the part of the brain responsible for producing chemicals that satisfy the desire for nicotine. If this is correct, then the user will replace the need for nicotine with the pleasant treatment experience of light and music therapy."*[^9] The full trial description goes further: *"The theoretical principle at work is the competition for absorption by **nicotinic cholinergic receptors located in the brain** by nicotine or by the LLLT and music therapy."*[^8] This is not an inference, a promotional claim, or a secondhand interpretation. It is Craig Nabat's company, in an IRB-approved clinical trial registered with the U.S. government, explicitly asserting that their laser + music platform **competes for brain neuroreceptor absorption**. The trial was registered in 2020, with last update January 28, 2026, and ran at NST Consultants, Inc. — the same regulatory consulting firm used for every iRestore FDA 510(k) submission.[^10][^9][^8] The trial design was a four-arm placebo-controlled study: LLLT + Music, LLLT Only, Music Only, and Sham. The device requires daily at-home use for 15 minutes — **identical session length to the current iRestore hair protocol**.[^10] ### 1.3 The 2016 "Mind and Body" Entrancing Headset: Same-Day Introduction as iRestore A 2016 press release announcing the simultaneous launch of iRestore and Freedom Laser's quit-smoking device described the latter as featuring *"a mind and body entrancing Relaxation Headset and a Craving Relief Spray."* Both products were introduced in a single announcement framed as "Two Innovations that Will Change Health and Beauty in 2016."[^11] This confirms that iRestore and a product explicitly described as producing "mind and body" effects were conceptually developed in parallel and launched simultaneously by the same founder. The hair-growth helmet and the entrancing relaxation headset are not separated by time or conceptual distance in the corporate record. ### 1.4 The SEC Regulation CF Filing: Brain, Opioids, and "Tranquil Music" in Official Investment Documents Freedom Laser, Inc.'s June 2024 SEC Regulation CF offering statement (CIK 2013219, filed via Netcapital) contains the following primary-source statements:[^12][^13] - The home-use quit-smoking device uses "8 infrared lasers" that "stimulate specific acupuncture points in the ears to boost the body's natural endorphin production to alleviate nicotine withdrawal symptoms." - "**Tranquil music assists the user to relax their mind and body.**" - The company explicitly plans to use its "patented laser tech for **opioid addiction**" treatment. - Business model includes partnerships with "16,000 US addiction treatment clinics," "medical distributors," "drugstores," and "insurance companies." - Craig Nabat holds 94.3% voting power. Co-patent holder is Mike Chen (former business partner). - Patent purchase price: US $50,000. The SEC filing also confirms that Freedom Laser, Inc. (the quit-smoking entity) is legally and operationally **separate from Freedom Laser Therapy, Inc.** (the iRestore entity), but is controlled by the same founder, Craig Nabat, and shares the same core laser-platform intellectual property.[^12] ### 1.5 The Clinical Protocol Reconstructed: Full Sensory-Behavioral Stack on Record Freedom Laser's clinical smoking-cessation procedure — documented in a 2009 YouTube video, a 2011 media reel, the company's current FAQ page, and a Beverly Hills Times article — involved:[^14][^15][^16] 1. **Low-level laser therapy** applied to acupuncture points on hands, face, wrist, and ears 2. **Simultaneous video viewing**: a 23-minute proprietary therapy video on psychological aspects of addiction 3. **Vitamin detox regimen** and nutritional supplementation 4. **Behavioral support kit**: craving relief spray, addiction workbook, commitment-to-success workbook 5. **Practitioner oversight** during the session For the drug and alcohol version (Freedom Laser Recovery), the same structure applied with a 6–10 session course.[^14] The consumer iRestore hair helmet preserves the following elements in compressed form: - Laser/LED stimulation (target shifted from ear acupuncture points to scalp follicles) - App-mediated habit loop with session logs, reminders, photo tracking - No audio (explicitly removed) - No practitioner - No nutritional protocol - No video education The FQS quit-smoking headset represents the **reconstruction** of the stripped audio layer — LLLT plus music, daily use, same 12–15 minute session length — now in a new regulatory context targeting brain receptor competition. ### 1.6 The Corporate Genealogy: Chen Family Manufacturing Link Trademark records from the FDA.report database for K151662 reveal that the IRESTORE mark was first co-filed in 2009 and 2011 jointly by Craig Nabat AND **Mike Chung-Yang Chen** (both filings dead/abandoned). The current iRestore FDA correspondent on K213094 (the 2021 iRestore ID-500 submission) is listed as **Wei-Chih (Kevin) Chen**.[^17][^18] Kevin Chen's own YouTube interview confirms: *"my dad... started a business... called Freedom Laser Therapy"*. Kevin Chen's LinkedIn and multiple podcast appearances confirm he is Co-Founder and President of iRestore, joining the business as early as 2013.[^19][^20][^21][^22] The structural picture: Craig Nabat (behavioral modification / nicotine addiction veteran) and Mike Chung-Yang Chen (manufacturing/operations partner, Kevin Chen's father) co-invented and co-trademarked the iRestore concept from the beginning in 2009. The Chen family built the e-commerce operation that scaled iRestore to eight figures. The Nabat-Chen patent on the quit-smoking device is perpetually licensed to Freedom Laser, Inc. with a purchase option of $50,000.[^12][^22][^23][^24] ### 1.7 The iRestore Platform Expansion: Hair → Face/Skin/NIR iRestore has quietly expanded its product line beyond hair:[^25][^26][^27] - **Illumina LED Face Mask**: 360 medical-grade LEDs, triple wavelength — Red (635nm), Infrared (**830nm**), Blue (415nm) - **Illumina Neck & Chest Mask**: Red and infrared therapy - Both sold as a bundle with the hair device as the "iRESTORE Pro Best Seller Bundle"[^28] - Pending 510(k) clearance for the masks as of late 2024/early 2025, CE certified[^29] - HSA/FSA eligible via Truemed partnership (August 2024)[^30][^31] - American Alchemy sponsor ad language has evolved to: *"Unlock your best hair & skin"*[^32][^33] **The 830nm wavelength is significant.** This is within the core near-infrared range (800–1064nm) used in transcranial photobiomodulation research. The Illumina Face Mask applies this wavelength to the **face, including the forehead** — in proximity to the frontal cortex. The product is not cleared as a neurological device, but the company has now voluntarily placed a NIR-emitting wearable on the human head without any disclosed brain-related testing. ### 1.8 Power-Escalation Trajectory in the OAP Classification The OAP product code (21 CFR 890.5500) has become a regulatory catch-basin for devices of dramatically increasing power:[^34][^35][^36] - Original laser comb predicates: single-digit watt total output - iRestore original (K151662, 2016): ~675 mW (based on predicate data) - iRestore Professional 282 (K183417, 2019): 1,410 mW[^37][^38] - iRestore Elite (K222081, 2022): **2,500 mW** — a full helmet covering the entire upper scalp[^39] Each new model was cleared as "substantially equivalent" to the prior one through predicate cascade. The regulatory framework has never been updated to address this power increase, nor the shift from laser combs (which part hair) to full-helmet arrays (which cover the entire cranial surface). The category name — "infrared lamp" — is technically inapplicable to 625–680nm visible red light under the statutory definition.[^35] *** ## 2. Hidden Continuities ### 2.1 The Audio Removal as Regulatory Strategy The iGrow's integrated headphone system was not incidental. It positioned the device as a combined sensory experience — light plus sound — during a 25-minute daily treatment. When Freedom Laser filed for iRestore clearance, removing the audio was the simplest path to demonstrating substantial equivalence without triggering review of the combined-modality design. The FDA accepted this.[^1][^2] The audio has since been reintegrated into Freedom Laser's *next* platform — the FQS quit-smoking device — now with the explicit claim that the audio+light combination targets brain neurochemistry. The audio was not abandoned; it was *deferred*.[^8][^9] ### 2.2 The Clinical Stack Was Always Multi-Sensory From the clinic protocol through the iGrow predicate through the current FQS device, the underlying design logic has consistently combined: - Photonic stimulation (laser/LED) - Acoustic input (music, guided audio) - Psychological framing (education videos, behavioral scripts) - Biochemical supplementation (vitamins, homeopathic sprays) The iRestore hair helmet is the single exception in which the stack was reduced to photonics only — specifically to obtain a simple predicate-match clearance at the lowest regulatory friction.[^14][^40] ### 2.3 The Shared Predicate Ecosystem and NST Consultants All iRestore clearances were filed through **NST Consultants, Inc.**, with Raymond Blanche as the regulatory consultant. The Freedom Laser quit-smoking clinical trial also lists NST Consultants as the sole study location. This means the same regulatory consultancy manages both the cosmetic hair product and the brain-neuroreceptor-targeting clinical program for the same founder.[^37][^41][^8][^42] NST Consultants has cleared multiple companies' hair-growth helmets through the OAP predicate cascade, including Grivamax (K171895) and others. They are experts in using the iGrow/iRestore predicate chain to achieve clearance for successive devices. Their institutional knowledge of the regulatory pathway is a strategic asset for anyone seeking to introduce new head-worn photonic devices under the existing classification.[^42] ### 2.4 Mike Chen / Kevin Chen Continuity The co-inventor of iRestore (Mike Chung-Yang Chen) and the current Co-Founder/President of iRestore (Wei-Chih / Kevin Chen, his son) represent a family-held manufacturing and operational axis that has been continuous from the first trademark filing in 2009 through the current Elite product. This is not a company that has changed hands or pivoted teams. It is a single founder-pair (Nabat + Chen family) that has maintained control across two decades.[^19][^20][^21][^18] *** ## 3. Strange but Defensible Possibilities ### 3.1 The Hair Helmet as Regulatory Holding Pattern iRestore may be best understood as a **regulatory incubation product**: a device that achieved FDA clearance in the least contested classification possible (cosmetic hair regrowth), built a consumer-installed base exceeding 500,000 units, normalized daily head-worn photonic habituation, and generated the longitudinal photo data and adherence infrastructure that would be needed for a future medical platform — all while the company's actual neurobiological ambitions were being developed in parallel under a separate legal entity (Freedom Laser, Inc.) and tested under a separate clinical trial (NCT04830384).[^43] This is not a conspiracy. It is standard regulatory product strategy: use the path of least resistance to build market presence while pursuing more ambitious claims elsewhere. ### 3.2 The Sensory-Stack Reconstruction Is Already Underway The FQS quit-smoking device represents the explicit reconstruction of the stripped sensory stack — LLLT plus music, ear-targeted, daily at-home use, 15-minute sessions, brain receptor mechanism claimed. If approved by the FDA, this device would represent the first consumer product from Freedom Laser that makes direct neurological claims, has IRB and clinical backing, and re-integrates audio-photonic combined stimulation. The gap between this device and an audio-enhanced version of the scalp helmet is architectural, not conceptual.[^9][^44] ### 3.3 The Illumina Face Mask Introduces NIR on the Head The addition of 830nm near-infrared to the iRestore product line — applied to the face and forehead — represents the company's first voluntary use of a wavelength with established transcranial PBM efficacy literature. This happened without any disclosed testing for brain effects and without a new regulatory classification discussion. Whether this was intentional or incidental, it advances the cranial NIR hardware footprint into the company's consumer ecosystem.[^45] ### 3.4 The Installed Base as the Real Asset With 500,000+ users accustomed to wearing a head-mounted photonic device for 12 minutes daily, the most valuable asset iRestore has may not be its current feature set. It is the normalized behavioral pattern: putting a light-emitting helmet on your head every day, syncing an app, and logging the results. This is the behavioral substrate on which any future overlay — adaptive dosing, EEG-pairing, NIR upgrade, cognitive-state monitoring — could be deployed, either through firmware update or next-generation device upgrade.[^43] ### 3.5 The Psychographic Funnel Is Coherent American Alchemy sponsorships have included episodes covering:[^46][^47][^32][^48][^33][^49] - Dan Sherman (NSA Project Preserve Destiny, alien communication via genetically modified human receptors) - Tim Alberino (Book of Enoch, fallen angel genetic modification, alien-human hybrids, Kandahar Giant) - "The Scientist That Scanned Beneath the Pyramids" - Multiple episodes on UFO disclosure, simulation theory, and consciousness-edge science In each episode's description, iRestore appears as a sponsor alongside AG1. The ad copy in April 2026 reads: *"Unlock your best hair & skin with @iRestorelaser and HUGE savings on the iRESTORE Elite + Illumina Face Mask Bundle with code [JESSE]."*[^32] The audience for this content is a specific demographic: male, 25–45, interested in anomalous technology, transhumanist edge cases, consciousness research, and post-biological self-optimization. This is also the audience most likely to be interested in neurotechnology, cognitive enhancement, and cranial modification. The simplest explanation is broad direct-response reach-buying. The less simple explanation is a deliberate long-term psychographic positioning of the brand as an ancestral node in a future human-enhancement stack. *** ## 4. What Would Matter Most if Found The following documents, if located, would change the picture significantly: 1. **The full patent specification** of the Craig Nabat / Mike Chen US patent on the FQS quit-smoking device — particularly the claims section, which would reveal whether the patent covers only the ear-targeted smoking-cessation application or extends to broader "stimulation of brain neuroreceptors via combined LLLT and audio." The SEC filing confirms US and China patents exist but does not provide patent numbers.[^12] 2. **Any Freedom Laser / iRestore investor materials, pitch decks, or strategy documents** that describe a platform roadmap beyond hair. The company is a private e-commerce operator and has not disclosed these. 3. **The iRestore app's full privacy policy and App Store data-type disclosures**, specifically whether photo metadata (including face and scalp images), session timing, geographic location, and biometric proxies are transmitted to third parties or retained for training. The App Store page states only: *"The app only stores the data you choose to save, including session logs, photos, and notes."* This is insufficient for forensic analysis.[^50][^51] 4. **NCT04830384 results data**, which has not been published. The study is listed as completed/suspended with 28 subjects. The primary outcome — whether LLLT+music reduced brain nicotinic receptor demand better than LLLT alone, music alone, or sham — would be the first primary-source experimental evidence of whether the company's neuroreceptor-competition theory has empirical support. 5. **Any Freedom Laser reimbursement or prior-authorization applications** to insurance companies — referenced in the SEC filing as a planned distribution channel. An insurance application would contain a clinical rationale that could reveal how the company internally frames the mechanism of action. 6. **Archived product pages or catalogs** from Remax Medi-Tech (Shenzhen) showing their complete product range — specifically whether they manufacture neurological PBM devices beyond hair helmets. Current available information describes them only as a "laser hair growth system" manufacturer, but their full catalog is not publicly documented in English.[^52] *** ## 5. Kill Shots The following findings would most powerfully weaken the ambitious interpretation: 1. **The FQS trial returned null results**: If NCT04830384 showed no significant difference between LLLT+music and sham on nicotinic craving reduction, the brain-receptor competition theory would be falsified in the company's own data. The product would be revealed as a behavioral ritual with no detectable neurochemical effect. 2. **The sponsorship is purely demographic reach-buying with no editorial relationship**: If it could be shown that iRestore's media-buy agency simply targets a demographic that over-indexes on podcasts — and that Jesse Michels' show happens to reach that demographic efficiently, regardless of topic — the memetic positioning argument would reduce to ordinary direct-response advertising. This is the most plausible alternative explanation for the sponsorship pattern. 3. **The 625–680nm wavelengths cannot penetrate bone**: If Monte Carlo photon-transport modeling confirms that visible red at 625–680nm is effectively absorbed in superficial tissue layers before reaching the meninges, then the entire off-target brain-stimulation hypothesis becomes physically implausible regardless of power output or coverage area. The 810–1064nm near-infrared case for tPBM does not automatically extend to visible red. This is the strongest scientific objection and remains partially open.[^45] 4. **Remax Medi-Tech has no brain/neurological device production**: If Remax makes only hair-growth helmets and has no overlap with clinical PBM, EEG, or neuromodulation supply chains, the manufacturing-side inference of platform adjacency is weakened. 5. **Freedom Laser's quit-smoking device never obtains FDA approval**: If the FQS device fails clinical trials or FDA review, the brain-neuroreceptor pathway is formally closed for this company, and iRestore's cosmetic positioning becomes indefinitely stable. 6. **Kevin Chen (iRestore's operational CEO) has no interest in neurotechnology**: Kevin Chen's public positioning as an e-commerce operator focused on DTC hair products provides strong counterevidence that the operational leadership of the iRestore brand has any intent to pursue neurotechnology applications. Craig Nabat's neurological ambitions (smoking cessation, opioid addiction) are housed in a legally separate entity.[^22][^23][^24] *** ## 6. Bottom Line The second-wave evidence makes iRestore look **considerably more like a domesticated descendant of behavioral neuro-modulation hardware than a conventional cosmetic device** — but not in the way conspiracy frameworks typically imagine. The architecture is not of a covert program. It is the architecture of a **founder with a genuine theory about laser-mediated brain neurochemistry** (documented in official clinical trial language and SEC filings) who built three different product lines around variations of the same core technology: - A **clinical behavioral-modification laser** (smoking cessation clinic, 2003–present) - A **consumer scalp photonics platform** with the audio stripped (iRestore hair, 2016–present) - A **combined laser+audio brain-receptor device** with audio restored (FQS quit-smoking, 2020–pending FDA approval) The consumer hair helmet is the regulatory and commercial enabler — the product that built the cash flow, the installed base, the brand, and the regulatory track record needed to support the more ambitious medical program. The multi-sensory neurological platform was not abandoned when iRestore launched. It was held in reserve and is now being actively re-pursued under IRB and regulatory supervision in a separate entity. The second-wave findings most materially advance the thesis as follows: | Layer | First-Wave Status | Second-Wave Status | Key New Source | |-------|-------------------|-------------------|----------------| | Sensory-stack compression | Inferred | **Confirmed by primary source** | FDA K151662 [^1] | | Company's brain neuroreceptor claim | Absent | **Present in official IRB/clinical trial** | NCT04830384 [^8][^9] | | "Tranquil music" brain modulation claim | Absent | **Present in SEC filing and crowdfunding** | SEC CF 2024 [^12] | | Audio layer removal as regulatory strategy | Plausible | **Confirmed** | FDA K151662 [^2] | | Full clinical sensory stack documented | Partial | **Fully reconstructed** | freedomquitsmoking.com FAQ [^16]; YouTube 2009 [^14] | | Corporate genealogy | Craig Nabat | **Nabat + Chen family, continuous since 2009** | Trademark records [^18]; Kevin Chen YouTube [^20] | | Product expansion to NIR | Not present | **Illumina 830nm face mask** | irestorelaser.com/pages/skin [^25] | | HSA/FSA reimbursement track | Not present | **Active, Truemed partnership 2024** | Truemed [^30][^31] | | Sponsorship language evolution | Hair only | **"Hair & skin"** confirmed | YouTube description April 2026 [^32] | | Regulatory creep / power escalation | Inferred | **Confirmed, 675mW → 2,500mW via predicate cascade** | K151662, K222081 [^1][^39] | **The most defensible post-wave-two reading:** iRestore is the consumer-facing, legally insulated, commercially self-sustaining arm of a laser-therapy platform that its founder has always understood as operating on brain neurochemistry. The hair-growth application was chosen not because it is the company's ultimate vision, but because it is the most permissive regulatory category available for a head-worn photonic device. The audio was stripped to obtain clearance and is being rebuilt into a parallel product. The NIR wavelength has been reintroduced through a skin mask that covers the forehead. The brand is now sponsoring content about consciousness, alien genetic modification of human brains, and NSA programs that "train humans to think in frequencies." None of this constitutes evidence of malicious intent or covert neurotechnology deployment. It does constitute strong circumstantial evidence that the company's founder holds a theory of laser-mediated neurological modulation that predates, underlies, and continues to surround the iRestore hair product — and that the infrastructure being assembled around iRestore (installed base, app telemetry, HSA/FSA eligibility, skin/NIR expansion, clinical trials in a parallel entity) is structurally compatible with a future platform transition, regardless of whether that transition is currently planned. *** ## Signal Ranking Table | Overlay | Signal Strength | Evidentiary Quality | Relevance to Ambitious Interpretation | Main Limitation | |---------|----------------|--------------------|------------------------------------|----------------| | Sensory-stack compression (audio removal) | **High** | **Primary source (FDA K151662)** | Confirms deliberate stripping of multi-sensory platform | Stated as "no significance" by FDA | | Brain neuroreceptor claim in IRB trial | **High** | **Primary source (ClinicalTrials.gov)** | Freedom Laser explicitly claims brain receptor mechanism | Separate product; trial suspended/incomplete | | "Tranquil music / mind and body" in SEC filing | **High** | **Primary source (SEC EDGAR 2024)** | Direct language in official investor document | Refers to quit-smoking product, not iRestore | | Corporate genealogy continuity (Nabat + Chen) | **High** | Primary source (trademark records, YouTube) | Same team from 2009 through present | Does not establish neurotechnology intent | | Illumina 830nm NIR on face/forehead | **Medium-High** | Direct evidence (product spec) | Voluntary head NIR introduction without brain-effect testing | No tPBM claims made; cosmetic framing | | OAP regulatory power escalation | **Medium-High** | Primary source (multiple 510ks) | Classification not designed for 2,500mW cranial arrays | Regulatory drift, not covert strategy | | American Alchemy sponsorship habitat | **Medium** | Direct evidence (episode descriptions) | Psychographic targeting of consciousness-edge audience | Demographic reach-buying cannot be ruled out | | HSA/FSA reimbursement track | **Medium** | Primary source (Truemed, LinkedIn) | Moves toward medical/therapeutic positioning | Standard for many wellness devices | | Product expansion (hair → skin → face NIR) | **Medium** | Direct evidence (irestorelaser.com) | Platform logic emerging | No explicit cranial or brain claims | | App telemetry / photo-data | **Low-Medium** | Indirect (App Store description) | Digital phenotyping grammar present | No evidence of biometric extraction | | Adjacent brain-PBM patent ecosystem | **Medium** | Primary source (third-party patents) | Shows where category is going | No overlap with Freedom Laser patents | | "Continuity / consciousness / digital twin" language | **None** | Absence confirmed | Not supported | No evidence in any Freedom Laser document | --- ## References 1. [[PDF] 510(k) Summary - accessdata.fda.gov](https://www.accessdata.fda.gov/cdrh_docs/pdf15/k151662.pdf) - Regulation Number: 21 CFR 890.5500. Regulation Name: Infrared Lamp. Regulatory Class: Class II. Prod... 2. [510(k) Summary - Food and Drug Administration](https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151662.pdf) 3. [iGrow Light Therapy for Hair Restoration | The Wise Institute for Hair ...](https://www.drwisehair.com/igrow/) - The device also has a 2.5mm audio port and patented headphone stabilizing platform which allows you ... 4. [iGrow Laser Hair-Growth Helmet – Revolutionary Non-Surgical way ...](https://igrowhairindia.com/product/igrow-laser-hair-growth-system-revolutionary-non-surgical-way-to-regrow-hair/) - The iGrow Laser LED Hair-Growth and Rejuvenation Helmet is a New World Best-Seller [USFDA Cleared], ... 5. [iGrow For Hair Loss - Bernstein Medical Center for Hair Restoration](https://www.bernsteinmedical.com/medical-treatment/laser-therapy/igrow/) - The iGrow incorporates a proprietary dual light Laser and LED design and comes equipped with headpho... 6. [iGrow Laser Hair Growth System - McGrath Medical](https://mcgrathmedical.com/hair-restoration/igrow_laser_hair/) - Equiped with high quality headphones to listen to your favorite music. *Results may vary. 7. [iGrow Hair Restoration System Now FDA Cleared for OTC for Women](https://www.thehairsociety.org/igrow-hair-restoration-system-now-fda-cleared-for-otc-for-women/) - The helmet, which includes a pair of headphones for listening to music or podcasts from your tablet ... 8. [Evaluation Into the Efficacy of Low Level Laser/Light and Music as a ...](https://www.patlynk.com/trial/NCT04830384) - Find clinical trials tailored to your needs. 9. [Evaluation of LLLT/Music for Smoking Cessation](https://ctv.veeva.com/study/evaluation-of-lllt-music-for-smoking-cessation) - The purpose of this research is to study the preliminary effectiveness of a light therapy and music ... 10. [Evaluation of LLLT/Music for Smoking Cessation - GoodDay - Xogene](https://dev-multi-sponsor-trials.xogene.com/trials/4830384) - The purpose of this research is to study the preliminary effectiveness of a light therapy and music ... 11. [Freedom Laser Therapy Introduces the Two Innovations that Will ...](https://www.prweb.com/releases/freedom_laser_therapy_introduces_the_two_innovations_that_will_change_health_and_beauty_in_2016/prweb13187779.htm) - His latest innovation – the iRestore Hair Growth System – is a FDA-cleared device to treat hair loss... 12. [Offering Statement for](https://www.sec.gov/Archives/edgar/data/2013219/000166919124000781/offeringstatement.pdf) 13. [[PDF] Offering Statement for Freedom Laser, Inc. - SEC.gov](https://www.sec.gov/Archives/edgar/data/2013219/000166919124000671/offeringstatement.pdf) - Craig Nabat's former business partner, Mike Chen, and Craig Nabat co-own the U.S. patent for the las... 14. [Freedom Laser Therapy Recovery- Drug & Alcohol Program](https://www.youtube.com/watch?v=ow6A2MSoBCU) - www.freedomlasertherapy.com www.freedomquitsmoking.com Freedom Laser Therapy of Los Angeles, estab... 15. [Freedom Laser Media Reel: Quit Smoking or Quit Vaping Today with Low-Level Laser Therapy](https://www.youtube.com/watch?v=98CH3wRkxzc) - Experience how Freedom Laser is helping individuals break free from nicotine addiction with our inno... 16. [Quit Smoking & Vaping FAQs — Freedom Laser, LLC](https://www.freedomquitsmoking.com/faqs) - Explore common FAQs about our Los Angeles-based quit smoking and vaping laser therapy procedure. Lea... 17. [510(k) Premarket Notification - FDA](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213094) - 510(k) Premarket Notification ; ID-500 iRestore Hair Growth System · Freedom Laser Therapy, Inc. 167... 18. [IRestore - Freedom Laser Therapy, Inc. - FDA.report](https://fda.report/PMN/K151662) - Pre-market Notification Details ; Device ID, K151662 ; 510k Number, K151662 ; Device Name: IRestore ... 19. [Kevin Chen - iRestore Laser (Freedom Laser Therapy) | LinkedIn](https://www.linkedin.com/in/kevin-chen-a5ab6b21) - Co-founder at iRestore. We're all about making best-in-class hair regrowth devices and… · Experience... 20. [Kevin Chen - Co-Founder & President of iRestore Laser - YouTube](https://www.youtube.com/watch?v=onLhzbvPTUo) - Kevin Chen - Co-Founder & President of iRestore Laser · Comments. 21. [Kevin Chen - Co-Founder / President at Freedom Laser Therapy](https://theorg.com/org/freedom-laser-therapy/org-chart/kevin-chen) - Previously, they co-founded and served as the president of iRestore Laser (Freedom Laser Therapy) st... 22. [197: The Inside Story of How iRestore Scaled to 8 Figures](https://podcasts.apple.com/gb/podcast/197-the-inside-story-of-how-irestore-scaled-to-8-figures/id880284109?i=1000436874714) - Kevin Chen is Vice President and co-founder of iRestore, a company that sells laser hair growth syst... 23. [268: How A Pivot In This Founder’s Role & COVID-19 Led To 100% Year-Over-Year Growth](https://www.youtube.com/watch?v=x0hxmv6Kfsg) - How A Pivot In This Founder’s Role & COVID-19 Led To 100% Year-Over-Year Growth. COVID-19 is present... 24. [Meet The Inventor Making $8.3 Million a Month (Curing Hair Loss)](https://www.youtube.com/watch?v=Vp0qQw4UiQc) - Kevin Chen is the Co-Founder & CEO of iRESTORE. iRESTORE fights hair loss and reverses skin aging wi... 25. [iRESTORE Skincare - Clinical-Grade LED Red Light Therapy](https://www.irestorelaser.com/pages/skin) - Address your biggest skin concerns using clinically tested LED technology, paired with skincare spec... 26. [Shop – iRESTORE Laser Hair Growth System | FDA Cleared](https://irestorelaser.in/shop/) 27. [Illumina LED Duo | Face and Décolletage areas - iRESTORE](https://www.irestorelaser.com/products/illumina-led-duo) - Dual coverage for face & chest with red, infrared & blue light. Improves wrinkles, acne & firmness i... 28. [iRESTORE Pro Best Seller Bundle | Hair & Skin System](https://www.irestorelaser.com/products/professional-best-seller-bundle) - Bundle includes Pro device, Illumina Face Mask & Neck/Chest Mask for complete hair regrowth and skin... 29. [Review And Demo Of The iRESTORE Illumina LED Mask: All-in-one Anti Aging And Acne Solution](https://www.youtube.com/watch?v=Yen4q5SbwSQ) - ✔ SHOP the iRESTORE Illumina LED Mask: https://glnk.io/beautybeyond40_ Use code BEAUTYBEYOND for $20... 30. [iRESTORE - HSA / FSA eligible for qualified customers - Truemed](https://www.truemed.com/shop/partners/irestore) - Ideal for thinning hair, iRestore improves follicle strength and circulation, helping to manage chro... 31. [Truemed's Post - LinkedIn](https://www.linkedin.com/posts/truemedpayments_welcomeirestore-laser-freedom-laser-therapy-activity-7228885178490781696-bNfI) - Customers who have certain health conditions may now be eligible to make purchases of their products... 32. [“We Captured a 12 Foot Giant in Afghanistan!” -Tim Alberino](https://www.youtube.com/watch?v=CiQTBOQ1dTg) - Sign Up With Our Sponsors Below For Exclusive Alchemy Deals! iRestore: Unlock your best hair & skin ... 33. [“We Captured a 12 Foot Giant in Afghanistan!” -Tim Alberino](https://www.youtube.com/watch?v=CiQTBOQ1dTg&list=TLPQMDUwNDIwMjYlqbqeGfJZqQ&index=27) - Our American Alchemist this week is Tim Alberino. Sign Up With Our Sponsors Below For Exclusive Alc... 34. [Mapping the genealogy of medical device predicates in the United ...](https://pmc.ncbi.nlm.nih.gov/articles/PMC8496833/) - In the United States, medical devices are regulated and subject to review by the Food and Drug Admin... 35. [21 CFR § 890.5500 - Infrared lamp. - Law.Cornell.Edu](https://www.law.cornell.edu/cfr/text/21/890.5500) - § 890.5500 Infrared lamp. (a) Identification. An infrared lamp is a device intended for medical purp... 36. [21 CFR 890.5500 -- Infrared lamp. - eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-890/subpart-F/section-890.5500) - An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies... 37. [[PDF] Freedom Laser Therapy, Inc. Mr. Raymond Blanche Consultant NST ...](https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183417.pdf) - The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alope... 38. [iRESTORE Professional | FDA-Cleared Hair Growth Device](https://www.irestorelaser.com/products/laser-hair-growth-system-professional) - Total Power Output: 1410mW · Light Source: 282 Diodes (82 Lasers & 200 LEDs) · Laser Power Classific... 39. [[PDF] October 13, 2022 Freedom Laser Therapy, Inc. Sharon Chen ...](https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222081.pdf) - The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-. Hamilton C... 40. [Freedom Laser Therapy Procedure to Quit Smoking & Quit Vaping](https://www.freedomquitsmoking.com/laser-therapy-procedure) - Our procedure uses low-level laser therapy based on the principles of acupuncture to enhance overall... 41. [510(k) Premarket Notification - FDA](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=k151662) - 510(k) Premarket Notification ; K151662 · K151662 · iRestore · Freedom Laser Therapy, Inc. 7815 Beve... 42. [[PDF] August 22, 2017 Leana Orders, Inc. Raymond Blanche Managing ...](https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171895.pdf) - ℅ Raymond Blanche. Managing Member. NST Consulting, LLC. 641 Shunpike Road. Chatham, New Jersey 0792... 43. [IRESTORE LED Face Mask Light Therapy | Blue, Infrared & Red](https://www.bumblelane.com/products/irestore-led-face-mask-light-therapy-blue-infrared-red) - Utilizing 360 LEDs, the IRESTORE LED Face Mask Light Therapy device is a top-of-the-line option for ... 44. [The Freedom Quit Smoking Laser: Break Free from Nicotine Addiction](https://www.youtube.com/watch?v=MNrh30NDY8w) - Discover how the Freedom Quit Smoking Laser is revolutionizing smoking cessation with a drug-free, h... 45. [Devices used for photobiomodulation of the brain—a ... - PMC - NIH](https://pmc.ncbi.nlm.nih.gov/articles/PMC11007916/) - A systematic review was conducted to determine the trends in devices and parameters used for brain p... 46. [“The NSA Hired Me To Speak To Aliens!” -Sergeant Dan Sherman](https://www.globalplayer.com/podcasts/episodes/7Dru9ew/) - Our American Alchemist this week is Dan Sherman. A former NSA electronic intelligence specialist who... 47. [“The NSA Hired Me To Speak To Aliens!” -Sargeant Dan Sherman](https://pod.wave.co/podcast/american-alchemy/the-nsa-hired-me-to-speak-to-aliens-sargeant-dan-sherman) - Sherman claims to have worked in a deeply classified NSA program called Project Preserve Destiny (PP... 48. [The Scientist That Scanned Beneath The Pyramids [Exclusive ...](https://open.spotify.com/episode/2foy1NBG0oUGj4zVuujvhg) - Sign Up With Our Sponsors Below For Exclusive Alchemy Deals! iRestore: Reverse hair loss with @iRest... 49. [The Scientist That Scanned Beneath The Pyramids ... - Apple Podcasts](https://podcasts.apple.com/uy/podcast/the-scientist-that-scanned-beneath-the-pyramids/id1771917740?i=1000740117102) - iRestore: Reverse hair loss with @iRestorelaser and unlock HUGE savings on the iRestore ... American... 50. [iRESTORE - App Store](https://apps.apple.com/us/app/irestore/id6740624438) - The following data may be collected but it is not linked to your identity: Diagnostics. Privacy prac... 51. [iRESTORE - App Store](https://apps.apple.com/ca/app/irestore/id6740624438) - Download iRESTORE by Freedom Laser Therapy, Inc. on the App Store. See screenshots, ratings and revi... 52. [Remax Medi-tech (shenzhen) Corporation - medical device](https://bbs.fobshanghai.com/company/169493a2e89glv2.html) - Remax Medi-tech (shenzhen) Corporation ; Business Scope : medical device ; Information of Remax Medi...