Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ultraviolet Phototherapy Device

K-Number: K250425 · 2025-04-07

Decision Date2025-04-07
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultraviolet Phototherapy Device is a medical device manufactured by APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under approval 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. It is manufactured by APK Technology Co., Ltd.. The 510(k) number is K250425.

When was Ultraviolet Phototherapy Device approved by the FDA?

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

What company makes Ultraviolet Phototherapy Device?

Ultraviolet Phototherapy Device is manufactured by APK Technology Co., Ltd..

What is the FDA product code for Ultraviolet Phototherapy Device?

The FDA product code for Ultraviolet Phototherapy Device is FTC.

Related Clinical Trials

Other Devices by APK Technology Co., Ltd.

Related Devices (Code: FTC)

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.