Cleared Traditional

K872179 - CODMAN NEUROLASE LASER SYSTEM

K872179 is the FDA 510(k) clearance for CODMAN NEUROLASE LASER SYSTEM by Codman & Shurtleff, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K872179 · Codman & Shurtleff, Inc. · General & Plastic Surgery device
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Oct 1987
Decision
121d
Days
Class 2
Risk

K872179 is an FDA 510(k) clearance for the CODMAN NEUROLASE 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 Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on October 7, 1987 after a review of 121 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K872179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date October 07, 1987
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
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 900
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K872179.
INFRAGUIDE(TM)
K875115 · Cooper Lasersonics, Inc. · Feb 1988
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY
K873790 · Cooper Lasersonics, Inc. · Jan 1988
ULTRASPOT MICROMANIPULATOR
K873443 · Cooper Lasersonics, Inc. · Jan 1988
MODEL LS 860, CO2 LASER
K864562 · Cooper Lasersonics, Inc. · Apr 1987
MODEL LS 840, CO2 LASER
K864563 · Cooper Lasersonics, Inc. · Apr 1987
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
K862514 · Laserscope · Feb 1987