Cleared Abbreviated

K151721 - FIJI SUN FLUORESCENT TANNING UNIT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K151721 · Kdb Inc. (Dba) Sperti Sunlamp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
1093d
Days
Class 2
Risk

K151721 is an FDA 510(k) clearance for the FIJI SUN FLUORESCENT TANNING UNIT. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Kdb Inc. (Dba) Sperti Sunlamp (Crescent Springs, US). The FDA issued a Cleared decision on June 22, 2018 after a review of 1093 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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.

View all Kdb Inc. (Dba) Sperti Sunlamp devices

Submission Details

510(k) Number K151721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2015
Decision Date June 22, 2018
Days to Decision 1093 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
979d slower than avg
Panel avg: 114d · This submission: 1093d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 80
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