Cleared Traditional

K152336 - HEX tanning booth

K152336 is an FDA 510(k) clearance for HEX tanning booth, manufactured by J & B Products Ltd Dba Hex Tanning. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K152336 · J & B Products Ltd Dba Hex Tanning · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
257d
Days
Class 2
Risk

K152336 is an FDA 510(k) clearance for the HEX tanning booth. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by J & B Products Ltd Dba Hex Tanning (Saginaw, US). The FDA issued a Cleared decision on May 2, 2016 after a review of 257 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 J & B Products Ltd Dba Hex Tanning devices

FDA 510(k) Submission Details - K152336

510(k) Number K152336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2015
Decision Date May 02, 2016
Days to Decision 257 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 115d · This submission: 257d
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 K152336.
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Sunrise 6200, Sunrise 7200
K173565 · Jk Holding GmbH · Feb 2018
U.I. OCTOSON
K801675 · Ausonics Pty , Ltd. · Oct 1980
CLINICAL DATA SYSTEM (CAM) MODULE
K801029 · Adac Laboratories · May 1980