Hairmax Lasercomb
FDA 510(k) K103368 · Lexington International, LLC
510(k) numberK103368
Submission
- Device name
- Hairmax Lasercomb
- Applicant
- Lexington International, LLC
Washington, DC, US - Received
- November 17, 2010
- Decision date
- April 6, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
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| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…OAP · Traditional | Ziree Co., Ltd. | 06/26/2026SE |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…OAP · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/16/2026SE |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 06/16/2026SE |
| K251684 | Alma TED+ SystemOAP · Traditional | Alma Lasers, Inc. | 06/05/2026SE |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 01/23/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | Light Tree Ventures Europe B.V. | 12/24/2025SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 10/30/2025SE |
| K252325 | Hair Growth Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 10/22/2025SE |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 06/17/2025SE |
More from Shenzhen Kaiyan Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K180885 | HairMax LaserOAP · Traditional | 06/20/2018SE |
| K142573 | HairMax LaserComb, HairMax LaserCombOAP · Traditional | 12/01/2014SE |
| K112524 | Hairmax LasercombOAP · Special | 09/26/2011SE |
| K111714 | Hairmax Dual 12OAP · Traditional | 08/16/2011SE |
| K110233 | Hairmax LasercombOAP · Traditional | 05/27/2011SE |
| K093499 | Hairmax LasercombOAP · Special | 11/23/2009SE |
| K060305 | Hairmax LasercombOAP · Traditional | 01/18/2007SE |
Questions and answers
When was Hairmax Lasercomb cleared by the FDA?
Hairmax Lasercomb (K103368) received a 510(k) decision of Substantially Equivalent on April 6, 2011, 140 days after the submission was received.
What is the product code of K103368?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.