Cleared Traditional

K151370 - UV Lamps for Indoor Tanning Devices

K151370 is an FDA 510(k) clearance for UV Lamps for Indoor Tanning Devices, manufactured by Light Sources, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K151370 · Light Sources, Inc. · General & Plastic Surgery device
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Dec 2015
Decision
210d
Days
Class 2
Risk

K151370 is an FDA 510(k) clearance for the UV Lamps for Indoor Tanning Devices. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Light Sources, Inc. (Orange, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 210 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 Light Sources, Inc. devices

FDA 510(k) Submission Details - K151370

510(k) Number K151370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2015
Decision Date December 17, 2015
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
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 32
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K151370.
3400E series
K151905 · Heartland Tanning, Inc. · Mar 2016
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
Suntanning Lamps
K152436 · Interlectric Corporation · 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