Cleared Traditional

K152423 - Sunfire 32 Tanning Bed

Also marketed or referenced as:
Sunfire 24 Tanning Bed Sunfire 16 Tanning Canopy Sunfire 12R Tanning Canopy

K152423 is an FDA 510(k) clearance for Sunfire 32 Tanning Bed, manufactured by Sunfire Industries, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K152423 · Sunfire Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
268d
Days
Class 2
Risk

K152423 is an FDA 510(k) clearance for the Sunfire 32 Tanning Bed. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Sunfire Industries, Inc. (New Bern, US). The FDA issued a Cleared decision on May 20, 2016 after a review of 268 days - an extended review cycle.

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 Sunfire Industries, Inc. devices

FDA 510(k) Submission Details - K152423

510(k) Number K152423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2015
Decision Date May 20, 2016
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 13
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K152423.
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