Cleared Traditional

K151841 - Ultraviolet Sunlamps

K151841 is an FDA 510(k) clearance for Ultraviolet Sunlamps, manufactured by Wolff System Technology Corp.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K151841 · Wolff System Technology Corp. · General & Plastic Surgery device
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Oct 2015
Decision
91d
Days
Class 2
Risk

K151841 is an FDA 510(k) clearance for the Ultraviolet Sunlamps. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Wolff System Technology Corp. (Kennesaw, US). The FDA issued a Cleared decision on October 5, 2015 after a review of 91 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 Wolff System Technology Corp. devices

FDA 510(k) Submission Details - K151841

510(k) Number K151841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2015
Decision Date October 05, 2015
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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 Consultant

Cosmedico Light, Inc.
Steven Schlitt

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 - LEJ Booth, Sun Tan

All 33
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K151841.
Cosmedico Ultraviolet Lamps of Various Models
K152273 · Cosmedico Light, Inc. · Oct 2015
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
K152095 · Cosmedico Light, Inc. · Oct 2015
Ultraviolet Sun Tanning Lamp
K151674 · G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh · Oct 2015
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
K151400 · Jk Holding GmbH · Sep 2015
Various Brands of Ultraviolet Lamps
K150778 · Cosmedico Light, Inc. · May 2015
Tanning Lamp
K143043 · Unilam Co., Ltd. · Apr 2015