Cleared Traditional

K964076 - LASERSCOPE ERBIUM

Also marketed or referenced as:
YAG LASER SYSTEM AND ACCESSORIES

K964076 is the FDA 510(k) clearance for LASERSCOPE ERBIUM by Laserscope. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K964076 · Laserscope · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
89d
Days
Class 2
Risk

K964076 is an FDA 510(k) clearance for the LASERSCOPE ERBIUM. 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 Laserscope (San Jose, US). The FDA issued a Cleared decision on January 8, 1997 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laserscope devices

Submission Details

510(k) Number K964076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date January 08, 1997
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1170
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K964076.
DORNIER MEDILAS FIBER TOME LASER
K964760 · Dornier Medtech America, Inc. · Feb 1997
PARASCAN SCANNING DEVICE
K964520 · Laserscope · Feb 1997
OMNIPULSE/OMNIPULSE-MAX
K962632 · Trimedyne, Inc. · Jan 1997
CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER
K963094 · Cynosure, Inc. · Dec 1996
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
K963229 · Sharplan Lasers, Inc. · Nov 1996
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
K961935 · Sharplan Lasers, Inc. · Nov 1996