FDA 510(k)

Phototherapy System (DUV-COMBO)

Número K: K254234 · 2026-05-01

Data da decisão2026-05-01

Código do produtoFTC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phototherapy System (DUV-COMBO) is the device name listed in this FDA 510(k) record. The listed applicant is Choyang Medics Co., Ltd.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K254234. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phototherapy System (DUV-COMBO)?

Phototherapy System (DUV-COMBO) is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Choyang Medics Co., Ltd.. The 510(k) number is K254234.

When did Phototherapy System (DUV-COMBO) receive FDA 510(k) clearance?

Phototherapy System (DUV-COMBO) received FDA 510(k) clearance on 2026-05-01, under 510(k) number K254234.

Who is the listed applicant for Phototherapy System (DUV-COMBO)?

The FDA 510(k) record lists Choyang Medics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phototherapy System (DUV-COMBO)?

The FDA product code for Phototherapy System (DUV-COMBO) is FTC.

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Fonte oficial

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