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FDA 510(k)

Phototherapy System (DUV-COMBO)

K-Number: K254234 · 2026-05-01

ApplicantChoyang Medics Co., Ltd.
Decision Date2026-05-01
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Choyang Medics Co., Ltd.. The 510(k) number is K254234.

When was Phototherapy System (DUV-COMBO) approved by the FDA?

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

What company makes Phototherapy System (DUV-COMBO)?

Phototherapy System (DUV-COMBO) is manufactured by Choyang Medics Co., Ltd..

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

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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