Cleared Traditional

K180581 - UV Lamps for Sunlamp Products

K180581 is an FDA 510(k) clearance for UV Lamps for Sunlamp Products, manufactured by Feilo Sylvania Germany GmbH. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K180581 · Feilo Sylvania Germany GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
113d
Days
Class 2
Risk

K180581 is an FDA 510(k) clearance for the UV Lamps for Sunlamp Products. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Feilo Sylvania Germany GmbH (Erlangen, DE). The FDA issued a Cleared decision on June 22, 2018 after a review of 113 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 Feilo Sylvania Germany GmbH devices

FDA 510(k) Submission Details - K180581

510(k) Number K180581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date June 22, 2018
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
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

Nats Corp.
Steve Mlcoch

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 12
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K180581.
Ergoline Prestige 1600 Hybrid Performance
K180555 · Jk Holding GmbH · Oct 2018
ProSun sunlamp products, Luxura sunlamp products
K181455 · Prosun International, LLC · Sep 2018
FIJI SUN FLUORESCENT TANNING UNIT
K151721 · Kdb Inc. (Dba) Sperti Sunlamp · Jun 2018
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
K180576 · Lpi, Inc. · Apr 2018
Sunrise 6200, Sunrise 7200
K173565 · Jk Holding GmbH · Feb 2018
U.I. OCTOSON
K801675 · Ausonics Pty , Ltd. · Oct 1980