510(k) clearance
UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
- 510(k) number
- K262285
- Applicant
- Shijiazhuang Recovery Star Medical Device Co., Ltd.
- Decision date
- Oct 5, 2026
- Date received
- Jul 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FTC
- Device type
- Light, Ultraviolet, Dermatological
- Device class
- Class II
- Regulation
- 21 CFR 878.4630
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Shijiazhuang, CN