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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 K222377
Device Name Led Mask Platinum Md
Applicant
Cellreturn Co., Ltd.
237, Namdongseo-Ro. Namdong-Gu
Incheon,  KR 21634
Applicant Contact Ilsoo Kim
Correspondent
Bt Solutions, Inc.
Unit 904, Eonju-Ro 86-Gil 5 Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Do-Hyun Kim
Regulation Number878.4810
Classification Product Code
OHS  
Date Received08/05/2022
Decision Date 11/03/2022
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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