Cleared Traditional

K151905 - 3400E series

Also marketed or referenced as:
E5400 series E6400 series Sundazzler series

K151905 is an FDA 510(k) clearance for 3400E series, manufactured by Heartland Tanning, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K151905 · Heartland Tanning, Inc. · General & Plastic Surgery device
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Mar 2016
Decision
232d
Days
Class 2
Risk

K151905 is an FDA 510(k) clearance for the 3400E series. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Heartland Tanning, Inc. (Lees Summit, US). The FDA issued a Cleared decision on March 1, 2016 after a review of 232 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 Heartland Tanning, Inc. devices

FDA 510(k) Submission Details - K151905

510(k) Number K151905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date March 01, 2016
Days to Decision 232 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
117d slower than avg
Panel avg: 115d · This submission: 232d
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
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