HairMD
510(k) K152019
HairMD is a medical device (FDA Class II; FDA product code OAP, Laser, Comb, Hair) made by Trophy Skin, Inc., cleared under FDA 510(k) K152019 on 16 Nov 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152019 | Date16 Nov 2015 | StatusActive |
Official records
- FDA 510(k) database K152019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OAP
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code OAP (Laser, Comb, Hair).
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- Laser Hair Growth System (Laser Cap 128) by Hubei Yjt Technology Co., Ltd