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FDA 510(k)

Laser hair growth helmet

K-Number: K213025 · 2022-05-12

ApplicantKam Yuen Plastic Products , Ltd.
Decision Date2022-05-12
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Laser hair growth helmet is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K213025. 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 helmet?

Laser hair growth helmet is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K213025.

When did Laser hair growth helmet receive FDA 510(k) clearance?

Laser hair growth helmet received FDA 510(k) clearance on 2022-05-12, under 510(k) number K213025.

Who is the listed applicant for Laser hair growth helmet?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser hair growth helmet?

The FDA product code for Laser hair growth helmet 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 Kam Yuen Plastic Products , 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.

K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588K213027Laser Hair Growth CombK212907Aimanfun Lumea Comfort, A-2789/A-3588K190820Aimanfun Lumea Comfort

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

View on FDA Database →

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

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