UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)— 510(k) K262285
Substantially EquivalentShijiazhuang Recovery Star Medical Device Co., Ltd.
FDA 510(k) clearance K262285 for UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35), Substantially Equivalent on 2026-10-05. Applicant: Shijiazhuang Recovery Star Medical Device Co., Ltd.. Device class: 2.
Summary
Shijiazhuang Recovery Star Medical Device's UV Phototherapy Device is cleared in five models, from KZX-308nm-BL35 up to KZX-308nm-BL65. Product code FTC is ultraviolet dermatological lights. Each model number includes "308nm," but the record itself doesn't list output specifications or indications.
Class II, 21 CFR 878.4630. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
The company filed from Shijiazhuang, China. Review took 91 days (July 6 to October 5, 2026).
Clearance details
- Applicant
- Shijiazhuang Recovery Star Medical Device Co., Ltd.
- Product code
- Product code FTC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4630
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shijiazhuang, CN
Recent devices under product code FTC
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