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FDA 510(k)

Hair Growth Comb (X-GC01)

K-Number: K262254 · 2026-09-23

ApplicantGuangdong Ashmore Health Technology Co., Ltd.
Decision Date2026-09-23
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Growth Comb (X-GC01) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Ashmore Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K262254. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hair Growth Comb (X-GC01)?

Hair Growth Comb (X-GC01) is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Guangdong Ashmore Health Technology Co., Ltd.. The 510(k) number is K262254.

When did Hair Growth Comb (X-GC01) receive FDA 510(k) clearance?

Hair Growth Comb (X-GC01) received FDA 510(k) clearance on 2026-09-23, under 510(k) number K262254.

Who is the listed applicant for Hair Growth Comb (X-GC01)?

The FDA 510(k) record lists Guangdong Ashmore Health Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Growth Comb (X-GC01)?

The FDA product code for Hair Growth Comb (X-GC01) is OAP.

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK251684Alma TED+ SystemAlma Lasers, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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