Cleared Traditional

K152095 - Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)

K152095 is an FDA 510(k) clearance for Ultraviolet Lamps Intended for Use in S..., manufactured by Cosmedico Light, Inc.. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K152095

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
Combination Product No
PCCP Authorized No
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.

LEJ Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K152095.
UV Lamps for Indoor Tanning Devices
K151370 · Light Sources, Inc. · Dec 2015
Suntanning Lamps
K152436 · Interlectric Corporation · Dec 2015
Cosmedico Ultraviolet Lamps of Various Models
K152273 · Cosmedico Light, Inc. · Oct 2015
Ultraviolet Sun Tanning Lamp
K151674 · G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh · Oct 2015
Ultraviolet Sunlamps
K151841 · Wolff System Technology Corp. · Oct 2015
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
K151400 · Jk Holding GmbH · Sep 2015