Hair Growth Comb (X-GC01)— 510(k) K262254
Substantially EquivalentGuangdong Ashmore Health Technology Co., Ltd.
FDA 510(k) clearance K262254 for Hair Growth Comb (X-GC01), Substantially Equivalent on 2026-09-23. Applicant: Guangdong Ashmore Health Technology Co., Ltd.. Device class: 2.
Summary
The Hair Growth Comb (X-GC01) is filed under OAP, laser hair combs. The record doesn't give the number of light sources or the treatment schedule.
Class II, 21 CFR 890.5500. The record lists Physical Medicine as the advisory panel and General and Plastic Surgery as the review panel. It was a Traditional 510(k).
Guangdong Ashmore Health Technology Co., Ltd. filed from Foshan, China. Review took 83 days (July 2 to September 23, 2026).
Clearance details
- Applicant
- Guangdong Ashmore Health Technology Co., Ltd.
- Product code
- Product code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.