Cleared Traditional

K180576 - Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180576 · Lpi, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
45d
Days
Class 2
Risk

K180576 is an FDA 510(k) clearance for the Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite.... Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Lpi, Inc. (Johnson City, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 45 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lpi, Inc. devices

Submission Details

510(k) Number K180576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date April 19, 2018
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 114d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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