Cleared Traditional

COMPULSE CO2 SURGICAL LASER SYS. (K911852) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911852 · Laser Engineering, Inc. · General & Plastic Surgery device
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Jun 1991
Decision
42d
Days
Class 2
Risk

K911852 is an FDA 510(k) clearance for the COMPULSE CO2 SURGICAL LASER SYS.. 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 Laser Engineering, Inc. (Milford, US). The FDA issued a Cleared decision on June 7, 1991 after a review of 42 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 Laser Engineering, Inc. devices

Submission Details

510(k) Number K911852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date June 07, 1991
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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 537
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K911852.
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
K933715 · Boston Scientific Corp · Nov 1993
CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K922935 · Buckman Co., Inc. · Apr 1993
INCISOR I PULSED ND:YAG LASER SYSTEM
K922901 · Buckman Co., Inc. · Nov 1992
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · Abbott Laboratories · Jun 1988
CODMAN NEUROLASE LASER SYSTEM
K872179 · Codman & Shurtleff, Inc. · Oct 1987
CODMAN LASER BACKSTOP
K853626 · Codman & Shurtleff, Inc. · Feb 1986