Cleared Traditional

K152364 - uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS

K152364 is an FDA 510(k) clearance for uwe sun tanning beds/booths P90, manufactured by Pc Marketing, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K152364 · Pc Marketing, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
237d
Days
Class 2
Risk

K152364 is an FDA 510(k) clearance for the uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Pc Marketing, Inc. (Ridgefield, US). The FDA issued a Cleared decision on April 14, 2016 after a review of 237 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.

FDA 510(k) Submission Details - K152364

510(k) Number K152364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2015
Decision Date April 14, 2016
Days to Decision 237 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 115d · This submission: 237d
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 Consultant

Bentley Biomedical Consulting, LLC
Shepard G. Bentley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K152364.
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
K152452 · Medtek Lighting Corp D/B/A Peacock Tanning · May 2016
HEX tanning booth
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T-32
K152412 · Tanses Technologies, Inc. · Apr 2016
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
K152238 · Sun Capsule, Inc. · Mar 2016
3400E series
K151905 · Heartland Tanning, Inc. · Mar 2016
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K152141 · Blv Licht-Und Vakuumtechnik GmbH · Feb 2016
K152364 · uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
Download PDF FDA Summary Pc Marketing, Inc.