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FDA 510(k)

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

K-Number: K230134 · 2023-05-23

ApplicantHubei Yjt Technology Co.,Ltd
Decision Date2023-05-23
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 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 2023-05-23 under 510(k) number K230134. 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 Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002?

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Hubei Yjt Technology Co.,Ltd. The 510(k) number is K230134.

When did Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 receive FDA 510(k) clearance?

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 received FDA 510(k) clearance on 2023-05-23, under 510(k) number K230134.

Who is the listed applicant for Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002?

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 Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002?

The FDA product code for Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 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

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.

K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)K232356Laser Cap, Model: Hat-01

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.

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.K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.

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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