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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K251871
Device Name FEATHER 01 02 03 04 (Model:01)
Applicant
Heat IN A Click, LLC
Numiere 1975 Tigertail Blvd.
Dania,  FL  33004
Applicant Contact Guy Levi
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu Distr
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHS  
Date Received06/18/2025
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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