510(k) K262254
K262254 is an FDA 510(k) premarket notification submitted by Guangdong Ashmore Health Technology Co., Ltd. for the device "Hair Growth Comb (X-GC01)". The FDA issued a decision of Substantially Equivalent on Sep 23, 2026. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2026
- Date Received
- Jul 2, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Laser, Comb, Hair
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
- 510(k)
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v