Cleared Traditional

K083215 - INCISIVE FAMILY OF INPULSE ND:YAG LASERS

K083215 is an FDA 510(k) clearance for INCISIVE FAMILY OF INPULSE ND:YAG LASERS, manufactured by Incisive, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K083215 · Incisive, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
159d
Days
Class 2
Risk

K083215 is an FDA 510(k) clearance for the INCISIVE FAMILY OF INPULSE ND:YAG LASERS. 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 Incisive, LLC (Pleasanton, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 159 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 Incisive, LLC devices

FDA 510(k) Submission Details - K083215

510(k) Number K083215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2008
Decision Date April 08, 2009
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1861
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K083215.
LUME 2 SYSTEM, MODEL GA0005000
K083733 · Lumenis, Ltd. · May 2009
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
K083889 · Fotona D.D. · Apr 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
K090618 · Cynosure, Inc. · Apr 2009
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
K090410 · New Star Lasers, Inc. · Mar 2009
SYNCHRO HP PLATFORM
K082039 · El.En Electronic Engineering Spa · Mar 2009
AFFIRM CO2 AND AFFIRM CO2 HP
K081424 · Cynosure, Inc. · Mar 2009