FDA 510(k)

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

K-Number: K253231 · 2026-06-16

Decision Date2026-06-16

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Yjt Technology Co.,Ltd. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253231. 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 Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)?

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Hubei Yjt Technology Co.,Ltd. The 510(k) number is K253231.

When did Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) receive FDA 510(k) clearance?

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253231.

Who is the listed applicant for Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)?

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

What is the FDA product code for Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)?

The FDA product code for Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) is OAP.

Related Clinical Trials

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.

NCT03491267Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle NeogenesisCOMPLETED

Other records listing Hubei Yjt Technology Co.,Ltd as applicant

K232356Laser Cap, Model: Hat-01 K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

Related Devices (Code: OAP)

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.K251684Alma TED+ SystemAlma Lasers, Inc.K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.

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.