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The Tracker / September 2026 / K262254

510(k) cleared

Hair Growth Comb (X-GC01)

Guangdong Ashmore Health Technology Co., Ltd. · Sep 23, 2026 · K262254

FDA cleared the Hair Growth Comb (X-GC01) from Guangdong Ashmore Health Technology Co., Ltd. on Sep 23, 2026 under K262254, a traditional 510(k). The device falls under product code OAP, Laser, Comb, Hair, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jul 2, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guangdong Ashmore Health Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262254?

K262254 is the FDA 510(k) for Hair Growth Comb (X-GC01), submitted by Guangdong Ashmore Health Technology Co., Ltd.. FDA's decision date was Sep 23, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the Hair Growth Comb (X-GC01)?

Guangdong Ashmore Health Technology Co., Ltd., based in Foshan, is the applicant of record for K262254.

How long did the K262254 review take?

FDA received the submission on Jul 2, 2026 and issued its decision on Sep 23, 2026, 83 days later.

← All decisions in September 2026