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FDA 510(k)

Hair Growth Device

K-Number: K222477 · 2022-11-18

ApplicantDongguan Lescolton Medical Equipment Co., Ltd.
Decision Date2022-11-18
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Growth Device is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Lescolton Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222477. 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 Device?

Hair Growth Device is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Dongguan Lescolton Medical Equipment Co., Ltd.. The 510(k) number is K222477.

When did Hair Growth Device receive FDA 510(k) clearance?

Hair Growth Device received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222477.

Who is the listed applicant for Hair Growth Device?

The FDA 510(k) record lists Dongguan Lescolton Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Growth Device?

The FDA product code for Hair Growth Device 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.

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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