Cleared Special

K003781 - COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

K003781 is an FDA 510(k) clearance for COOLTOUCH VARIA-II ND:YAG LASER SYSTEM, manufactured by Cooltouch Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 13-day FDA review.

K003781 · Cooltouch Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
13d
Days
Class 2
Risk

K003781 is an FDA 510(k) clearance for the COOLTOUCH VARIA-II ND:YAG LASER SYSTEM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Cooltouch Corp. (Roseville, US). The FDA issued a Cleared decision on December 20, 2000 after a review of 13 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cooltouch Corp. devices

FDA 510(k) Submission Details - K003781

510(k) Number K003781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2000
Decision Date December 20, 2000
Days to Decision 13 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 2124
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K003781.
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
K003460 · Palomar Medical Technologies, Inc. · Jan 2001
DENLASER, MODEL 800
K003541 · CAO Group, Inc. · Jan 2001
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308 · Trimedyne, Inc. · Dec 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · Laserscope · Dec 2000
SCITON IMAGE HAIR REMOVAL LASER
K002853 · Sciton, Inc · Dec 2000
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
K002884 · Fotona D.D. · Dec 2000