Cleared Traditional

K132613 - SONILASE LIGHT THERAPY DEVICE

K132613 is an FDA 510(k) clearance for SONILASE LIGHT THERAPY DEVICE, manufactured by Biorenew Labs, LLC. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K132613 · Biorenew Labs, LLC · General & Plastic Surgery device
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Feb 2014
Decision
168d
Days
Class 2
Risk

K132613 is an FDA 510(k) clearance for the SONILASE LIGHT THERAPY DEVICE. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Biorenew Labs, LLC (Coralville, US). The FDA issued a Cleared decision on February 5, 2014 after a review of 168 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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.

View all Biorenew Labs, LLC devices

FDA 510(k) Submission Details - K132613

510(k) Number K132613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date February 05, 2014
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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 - OHS Light Based Over The Counter Wrinkle Reduction

All 121
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K132613.
reVive Light Therapy LED Ultrasonic Wrinkle System
K180445 · Led Technologies, Inc. · May 2018
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K180320 · Led Technologies, Inc. · Apr 2018
reVive Perioral
K172662 · Led Technologies, Inc. · Jan 2018
ILUMINAGE SKIN SMOOTHING LASER
K133473 · Cynosure, Inc. · Jan 2014
ILUMINAGE DIODE LASER
K111454 · Cynosure, Inc. · Jul 2012