510(k) clearance
Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
- 510(k) number
- K262183
- Applicant
- Shenzhen Nuon Medical Equipment Co., Ltd.
- Decision date
- Sep 24, 2026
- Date received
- Jun 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OAP
- Device type
- Laser, Comb, Hair
- Device class
- Class II
- Regulation
- 21 CFR 890.5500
- Advisory committee
- Physical Medicine
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN