Cleared Traditional

K110370 - Q-CLEAR

K110370 is an FDA 510(k) clearance for Q-CLEAR, manufactured by Light Age, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K110370 · Light Age, Inc. · General & Plastic Surgery device
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Sep 2011
Decision
219d
Days
Class 2
Risk

K110370 is an FDA 510(k) clearance for the Q-CLEAR. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Light Age, Inc. (Somerset, US). The FDA issued a Cleared decision on September 15, 2011 after a review of 219 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 Light Age, Inc. devices

FDA 510(k) Submission Details - K110370

510(k) Number K110370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2011
Decision Date September 15, 2011
Days to Decision 219 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
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDZ Device Classification - Class 2, Special Controls

Product Code PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition For The Temporary Increase Of Clear Nail In Patients With Onychomycosis (e.g., Dermatophytes Trichophyton Rubrum And T Mentagrophytes, And/or Yeasts Candida Albicans, Etc.).
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 - PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

All 12
Devices cleared under the same product code (PDZ) and FDA review panel - the closest regulatory comparables to K110370.
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810 · Alma Lasers, Inc. · Mar 2012
JOULE CLEARSENSE LASER SYSTEM
K111483 · Sciton, Inc · Dec 2011
COOLTOUCH
K103338 · New Star Lasers, Inc. · Nov 2011
CUTERA GENESISPLUS LASER SYSTEM
K103626 · Cutera, Inc. · Apr 2011