Cleared Traditional

K181455 - ProSun sunlamp products

K181455 is the FDA 510(k) clearance for ProSun sunlamp products by Prosun International, LLC. It is a Class 2 General & Plastic Surgery device (product code LEJ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K181455 · Prosun International, LLC · General & Plastic Surgery device
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Sep 2018
Decision
98d
Days
Class 2
Risk

K181455 is an FDA 510(k) clearance for the ProSun sunlamp products, Luxura sunlamp products. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Prosun International, LLC (Saint Petersburg, US). The FDA issued a Cleared decision on September 10, 2018 after a review of 98 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 Prosun International, LLC devices

Submission Details

510(k) Number K181455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2018
Decision Date September 10, 2018
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 11
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