Cleared Traditional

K873790 - MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY

K873790 is an FDA 510(k) clearance for MODELS 4000/6000/8000/8900 LASER FOR DE..., manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K873790 · Cooper Lasersonics, Inc. · General & Plastic Surgery device
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Jan 1988
Decision
126d
Days
Class 2
Risk

K873790 is an FDA 510(k) clearance for the MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY. 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 Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 126 days - within the typical 510(k) review window.

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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K873790

510(k) Number K873790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1987
Decision Date January 22, 1988
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
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 2402
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K873790.
INFRAGUIDE(TM)
K875115 · Cooper Lasersonics, Inc. · Feb 1988
MODEL 5202 MICROMANIPULATOR
K874811 · Coherent Medical Group · Feb 1988
COHERENT XA-30/SP CO2 SURGICAL LASER
K874648 · Coherent Medical Group · Feb 1988
ULTRASPOT MICROMANIPULATOR
K873443 · Cooper Lasersonics, Inc. · Jan 1988
SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER
K873760 · Coherent Medical Group · Nov 1987
MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2
K873246 · Coherent Medical Group · Nov 1987