Cleared Traditional

K103338 - COOLTOUCH

K103338 is an FDA 510(k) clearance for COOLTOUCH, manufactured by New Star Lasers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K103338 · New Star Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
351d
Days
Class 2
Risk

K103338 is an FDA 510(k) clearance for the COOLTOUCH. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by New Star Lasers, Inc. (Roseville, US). The FDA issued a Cleared decision on November 1, 2011 after a review of 351 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.

View all New Star Lasers, Inc. devices

FDA 510(k) Submission Details - K103338

510(k) Number K103338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date November 01, 2011
Days to Decision 351 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
236d slower than avg
Panel avg: 115d · This submission: 351d
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 11
Devices cleared under the same product code (PDZ) and FDA review panel - the closest regulatory comparables to K103338.
FOTONA XP ND: YAG LASER SYSTEM
K113702 · Fotona D.D. · Mar 2012
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810 · Alma Lasers, Inc. · Mar 2012
JOULE CLEARSENSE LASER SYSTEM
K111483 · Sciton, Inc · Dec 2011
CUTERA GENESISPLUS LASER SYSTEM
K103626 · Cutera, Inc. · Apr 2011