Cleared Traditional

K132518 - NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE

K132518 is an FDA 510(k) clearance for NUBRILLIANCE PULSED LIGHT HAIR REMOVAL ..., manufactured by Wellquest Intl., Inc.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K132518 · Wellquest Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
370d
Days
Class 2
Risk

K132518 is an FDA 510(k) clearance for the NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Wellquest Intl., Inc. (Austin, US). The FDA issued a Cleared decision on August 17, 2014 after a review of 370 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 878.4810 - 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. 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 - K132518

510(k) Number K132518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date August 17, 2014
Days to Decision 370 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
255d slower than avg
Panel avg: 115d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHT Device Classification - Class 2, Special Controls

Product Code OHT Light Based Over-the-counter Hair Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.
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 - OHT Light Based Over-the-counter Hair Removal

All 165
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K132518.
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SENSILIGHT MINI
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GLIDE DEVICE
K131870 · Home Skinovations , Ltd. · Aug 2013
K132518 · NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
Download PDF FDA Summary Wellquest Intl., Inc.