510(k) clearance

Hair Growth Comb (X-GC01)

FDA 510(k) source

510(k) number

K262254

Applicant

Guangdong Ashmore Health Technology Co., Ltd.

Decision date

Sep 23, 2026

Date received

Jul 2, 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

Statement

Third party

N

Location

Foshan, CN