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FDA 510(k)

HairMax Laser

K-Number: K180885 · 2018-06-20

ApplicantLexington International, LLC
Decision Date2018-06-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HairMax Laser is the device name listed in this FDA 510(k) record. The listed applicant is Lexington International, LLC. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K180885. 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 HairMax Laser?

HairMax Laser is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is Lexington International, LLC. The 510(k) number is K180885.

When did HairMax Laser receive FDA 510(k) clearance?

HairMax Laser received FDA 510(k) clearance on 2018-06-20, under 510(k) number K180885.

Who is the listed applicant for HairMax Laser?

The FDA 510(k) record lists Lexington International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HairMax Laser?

The FDA product code for HairMax Laser is OAP.

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Other records listing Lexington International, LLC 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.

K112524HAIRMAX LASERCOMBK111714HAIRMAX DUAL 12K110233HAIRMAX LASERCOMBK103368HAIRMAX LASERCOMBK093499HAIRMAX LASERCOMBK060305HAIRMAX LASERCOMB

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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.K262254Hair Growth Comb (X-GC01)Guangdong Ashmore Health Technology 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.,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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