Cleared Traditional

K151962 - KBL Sunlamp Products (= Device Bundling name)

K151962 is an FDA 510(k) clearance for KBL Sunlamp Products (= Device Bundling..., manufactured by Kbl AG. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 427-day FDA review.

K151962 · Kbl AG · 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
427d
Days
Class 2
Risk

K151962 is an FDA 510(k) clearance for the KBL Sunlamp Products (= Device Bundling name). Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Kbl AG (Dernbach, DE). The FDA issued a Cleared decision on September 15, 2016 after a review of 427 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K151962

510(k) Number K151962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date September 15, 2016
Days to Decision 427 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
312d slower than avg
Panel avg: 115d · This submission: 427d
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

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K151962 · KBL Sunlamp Products (= Device Bundling name)
Download PDF FDA Summary Kbl AG