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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K254234
Device Name Phototherapy System (DUV-COMBO)
Applicant
Choyang Medics Co., Ltd.
215, Galmachi-Ro, Jungwon-Gu
B-Dong 1003~1004-Ho, Geumgang Penterium It Tower
Seongnam-Si,  KR 13217
Applicant Contact Park Seung-Bum
Correspondent
SMB Korea Co.
7, Boramae-Ro 5ga-Gil, Dongjak-Gu
606~607-Ho
Seoul,  KR 07071
Correspondent Contact Kim Kyung-Hwan
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/29/2025
Decision Date 05/01/2026
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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