Cleared Traditional

K152095 - Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) (FDA 510(k) Clearance)

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

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
22d faster than avg
Panel avg: 114d · 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 80
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