Cleared Traditional

K152095 - Ultraviolet Lamps Intended for Use in S...

K152095 is the FDA 510(k) clearance for Ultraviolet Lamps Intended for Use in S... by Cosmedico Light, Inc.. It is a Class 2 General & Plastic Surgery device (product code LEJ) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K152095 · Cosmedico Light, Inc. · General & Plastic Surgery device
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Oct 2015
Decision
92d
Days
Class 2
Risk

K152095 is an FDA 510(k) clearance for the Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as met.... Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Cosmedico Light, Inc. (Weymouth, US). The FDA issued a Cleared decision on October 28, 2015 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4635 - 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 Cosmedico Light, Inc. devices

Submission Details

510(k) Number K152095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date October 28, 2015
Days to Decision 92 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEJ Booth, Sun Tan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
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 - LEJ Booth, Sun Tan

All 12
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K152095.
UV Lamps for Sunlamp Products
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Sunrise 6200, Sunrise 7200
K173565 · Jk Holding GmbH · Feb 2018
CLINICAL DATA SYSTEM (CAM) MODULE
K801029 · Adac Laboratories · May 1980