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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 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.

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. 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.

Related Devices (Code: FTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.K233811DT Controlled Phototherapy EquipmentDaavlin Distributing Co.

Official Source

View on FDA Database →

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

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