Cleared Traditional

UV Phototherapy (K181805) - FDA 510(k) Clearance

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

K181805 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
189d
Days
Class 2
Risk

K181805 is an FDA 510(k) clearance for the UV Phototherapy. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on January 11, 2019 after a review of 189 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 Kernel Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K181805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2018
Decision Date January 11, 2019
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 23
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K181805.
308nm Excimer System
K192642 · Chongqing Peninsula Medical Technology Co., Ltd. · May 2020
UV Radiation Treatment System
K191571 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Feb 2020
Exciplex
K191086 · Clarteis · Dec 2019
ClearLink Controlled Phototherapy Equipment
K182215 · Daavlin Distributing Company · Oct 2018
308nm Excimer System
K172273 · Chongqing Peninsula Medical Technology Co., Ltd. · Jul 2018
Luma Light System
K173436 · Luma Therapeutics · Jan 2018