K250425
- 510(k) number
- K250425
- Device name
- Ultraviolet Phototherapy Device
- Applicant
- APK Technology Co., Ltd. CN
- Product code
- FTC — Light, Ultraviolet, Dermatological
- Decision date
- 2025-04-07
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250425
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.