Cleared Traditional

K181805 - UV Phototherapy

K181805 is an FDA 510(k) clearance for UV Phototherapy, manufactured by Xuzhou Kernel Medical Equipment 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 189-day FDA review.

K181805 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery device
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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

FDA 510(k) Submission Details - K181805

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.

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 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 51
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K181805.
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K191086 · Clarteis · Dec 2019
ClearLink Controlled Phototherapy Equipment
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308nm Excimer System
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Luma Light System
K173436 · Luma Therapeutics · Jan 2018