Cleared Traditional

K262285 - UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)

K262285 is an FDA 510(k) clearance for UV Phototherapy Device (KZX-308nm-BL65, manufactured by Shijiazhuang Recovery Star Medical Device Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K262285 · Shijiazhuang Recovery Star Medical Device Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
91d
Days
Class 2
Risk

K262285 is an FDA 510(k) clearance for the UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-3.... Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Shijiazhuang Recovery Star Medical Device Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on October 5, 2026 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262285

510(k) Number K262285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2026
Decision Date October 05, 2026
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 273
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K262285.
308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)
K262885 · Guangxi Hope Medical Devices Technology Co., Ltd. · Oct 2026
Phototherapy System (DUV-COMBO)
K254234 · Choyang Medics Co., Ltd. · May 2026
Klär Lite (RCW-KL1000)
K253871 · Radcliffe Watts, LLC · Mar 2026
Ultraviolet Phototherapy Device
K250425 · APK Technology Co., Ltd. · Apr 2025
308nm UV Phototherapy System (UV-K)
K244022 · Boston Aesthetics, Inc. · Mar 2025
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
K242977 · Xuzhou Kernel Medical Equipment Co., Ltd. · Feb 2025
K262285 · UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
Download PDF FDA Summary Shijiazhuang Recovery…