510(k) K254234

Device
Phototherapy System (DUV-COMBO)
Applicant
Choyang Medics Co., Ltd.
510(k) number
K254234
Product code
FTC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2025-12-29
Regulation
878.4630
Classification name
Light, Ultraviolet, Dermatological
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Park Seung-Bum
Address
215, Galmachi-Ro, Jungwon-Gu B-Dong 1003~1004-Ho, Geumgang Penterium It Tower Seongnam-Si KR 13217 13217

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FTC

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