Cleared Traditional

K152405 - IBL 5000 Tanning Booth

K152405 is an FDA 510(k) clearance for IBL 5000 Tanning Booth, manufactured by Ibl Acquisitions, LLC. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K152405 · Ibl Acquisitions, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
373d
Days
Class 2
Risk

K152405 is an FDA 510(k) clearance for the IBL 5000 Tanning Booth. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Ibl Acquisitions, LLC (Indianapolis, US). The FDA issued a Cleared decision on September 1, 2016 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K152405

510(k) Number K152405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2015
Decision Date September 01, 2016
Days to Decision 373 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
258d slower than avg
Panel avg: 115d · This submission: 373d
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

Bender & Bender Project Management Services, LLC
GREG BENDER

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 K152405.
Sunrise 6200, Sunrise 7200
K173565 · Jk Holding GmbH · Feb 2018
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
K161394 · Sportarredo Group S.C. · Jul 2017
KBL Sunlamp Products (= Device Bundling name)
K151962 · Kbl AG · Sep 2016
Sunfire 32 Tanning Bed
K152423 · Sunfire Industries, Inc. · May 2016
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
K152452 · Medtek Lighting Corp D/B/A Peacock Tanning · May 2016
HEX tanning booth
K152336 · J & B Products Ltd Dba Hex Tanning · May 2016
K152405 · IBL 5000 Tanning Booth
Download PDF FDA Summary Ibl Acquisitions, LLC