Cleared Traditional

UV Radiation Treatment System (K191571) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191571 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
237d
Days
Class 2
Risk

K191571 is an FDA 510(k) clearance for the UV Radiation Treatment System. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Xuzhou Yongkang Electronic Science Technology Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on February 6, 2020 after a review of 237 days - an extended review cycle.

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.

View all Xuzhou Yongkang Electronic Science Technology Co., Ltd. devices

Submission Details

510(k) Number K191571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date February 06, 2020
Days to Decision 237 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
122d slower than avg
Panel avg: 115d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 271
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K191571.
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
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD)
K242908 · Shanghai Sigma High-Tech Co., Ltd. · Dec 2024