Cleared Traditional

K152436 - Suntanning Lamps

K152436 is an FDA 510(k) clearance for Suntanning Lamps, manufactured by Interlectric Corporation. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K152436 · Interlectric Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
102d
Days
Class 2
Risk

K152436 is an FDA 510(k) clearance for the Suntanning Lamps. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Interlectric Corporation (Warren, US). The FDA issued a Cleared decision on December 7, 2015 after a review of 102 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.

FDA 510(k) Submission Details - K152436

510(k) Number K152436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date December 07, 2015
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
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 50
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K152436.
High Pressure Tanning Lamps
K152141 · Blv Licht-Und Vakuumtechnik GmbH · Feb 2016
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
K152233 · Sportarredo Group S.C. · Jan 2016
UV Lamps for Indoor Tanning Devices
K151370 · Light Sources, Inc. · Dec 2015
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
K152436 · Suntanning Lamps
Download PDF Interlectric Corporat…