HairMax
| Private | |
| ISIN | 🆔 |
| Industry | Medical device |
| Founded 📆 | 2000 |
| Founders 👔 | David Michaels |
Area served 🗺️ | |
| Products 📟 | Low-level laser therapy (LLLT) hair growth devices |
| Members | |
Number of employees | |
| 🌐 Website | [Lua error in Module:WikidataIB at line 665: attempt to index field 'wikibase' (a nil value). ] |
| 📇 Address | |
| 📞 telephone | |
HairMax (operating as Hairmax International, LLC) is a private American medical device company headquartered in Boca Raton, Florida. The company develops and markets low-level laser therapy (LLLT) devices for the treatment of androgenic alopecia (pattern hair loss) in men and women. HairMax received its first 510(k) clearance from the Food and Drug Administration (FDA) for an at-home laser hair growth device in January 2007,[1] and has since received a total of eight FDA 510(k) clearances across its product line.
History
HairMax was founded in 2000 in Boca Raton, Florida by David Michaels, who had personally experienced hair loss and sought to develop a home-use low-level laser therapy solution.[2] The company was self-financed with an initial investment of approximately $300,000.[2]
The company commercially launched its first product, the HairMax LaserComb, in 2001.[3]
In January 2007, the FDA granted HairMax its first 510(k) clearance (K060305) for a laser phototherapy device intended to treat androgenetic alopecia in males.[4] In 2011, the FDA issued a subsequent clearance extending the indicated use to females.[5]
Products
HairMax's core product line uses low-level laser therapy (LLLT), also referred to as photobiomodulation, in which low-intensity laser light is applied to the scalp to stimulate hair follicles. Devices are designed for home use and are available in comb, band, and helmet form factors.
Clinical evidence
Published clinical studies
Three clinical studies of HairMax devices have been published in peer-reviewed journals:
- Leavitt, M., Charles, G., Heyman, E., and Michaels, D. (2009). "HairMax LaserComb Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia." Clinical Drug Investigation. PMID 19366270
- Jimenez, J.J., et al. (2014). "Efficacy and Safety of a Low-level Laser Device in the Treatment of Male and Female Pattern Hair Loss: A Multicenter, Randomized, Sham Device-controlled, Double-blind Study." Lasers in Surgery and Medicine. PMC 3986893
- Munck, A., et al. (2014). "Efficacy, Safety and Tolerability of an Energy-independent, Low-Level Light Therapy (LLLT) Device for Home Use in Male and Female Pattern Hair Loss: A Randomized, Double-blind, Sham Device-controlled Trial." International Journal of Trichology. 6(2):45–9.
A 2021 systematic review and meta-analysis of FDA-approved LLLT devices for androgenetic alopecia included HairMax devices among the randomized controlled trials reviewed.[6]
FDA clearances
HairMax has received the following 510(k) clearances from the U.S. Food and Drug Administration:
| 510(k) Number | Notes |
|---|---|
| K060305 | First clearance, January 2007 — male androgenetic alopecia |
| K093499 | |
| K110233 | |
| K103368 | |
| K112524 | |
| K111714 | |
| K142573 | |
| K180885 |
References
- ↑ Aamir, R.; et al. (2020). "Role of Low Level Light Therapy (LLLT) in Androgenetic Alopecia". Journal of Cutaneous and Aesthetic Surgery.
- ↑ 2.0 2.1 Taylor, Meggen (September 13, 2018). "HairMax Offer Hair Loss Sufferers The Fastest Low Level Laser Treatment In The Market". Forbes.
- ↑ "FDA clears laser-based comb to combat hair loss". Fierce Biotech.
- ↑ "510(k) K060305". U.S. Food and Drug Administration.
- ↑ "Role of Low Level Light Therapy (LLLT) in Androgenetic Alopecia". Journal of Cutaneous and Aesthetic Surgery. 2020.
- ↑ Lueangarun, Suparuj; Visutjindaporn, Poom; Parcharoen, Yardnapar; Jamparuang, Pollawat; Tempark, Therdpong (2021). "A Systematic Review and Meta-analysis of Randomized Controlled Trials of United States Food and Drug Administration-Approved, Home-use, Low-Level Light/Laser Therapy Devices for Pattern Hair Loss: Device Design and Technology". Journal of Clinical and Aesthetic Dermatology. 14 (11): E64–E75. PMC 8675345 Check
|pmc=value (help). PMID 34980962 Check|pmid=value (help).
External links
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