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FDA 510(k)

Ultraviolet Phototherapy Device

K-Number: K250425 · 2025-04-07

ApplicantAPK Technology Co., Ltd.
Decision Date2025-04-07
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultraviolet Phototherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K250425. 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 Ultraviolet Phototherapy Device?

Ultraviolet Phototherapy Device is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K250425.

When did Ultraviolet Phototherapy Device receive FDA 510(k) clearance?

Ultraviolet Phototherapy Device received FDA 510(k) clearance on 2025-04-07, under 510(k) number K250425.

Who is the listed applicant for Ultraviolet Phototherapy Device?

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

What is the FDA product code for Ultraviolet Phototherapy Device?

The FDA product code for Ultraviolet Phototherapy Device is FTC.

Other records listing APK Technology Co., Ltd. as applicant

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.

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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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK244022308nm 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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