Cleared Traditional

K902946 - PEGASUS W/ACCESSORIES FOR GENERAL SURGERY

K902946 is an FDA 510(k) clearance for PEGASUS W/ACCESSORIES FOR GENERAL SURGERY, manufactured by Pfizer Laser Systems. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K902946 · Pfizer Laser Systems · General & Plastic Surgery device
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Oct 1990
Decision
89d
Days
Class 2
Risk

K902946 is an FDA 510(k) clearance for the PEGASUS W/ACCESSORIES FOR GENERAL 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 Pfizer Laser Systems (Irvine, US). The FDA issued a Cleared decision on October 2, 1990 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 Pfizer Laser Systems devices

FDA 510(k) Submission Details - K902946

510(k) Number K902946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date October 02, 1990
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 1536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K902946.
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
K900858 · Candela Laser Corp. · Oct 1990
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K902939 · Trimedyne, Inc. · Oct 1990
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
K902940 · Trimedyne, Inc. · Oct 1990
PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION
K902947 · Pfizer Laser Systems · Oct 1990
PEGASUS WITH ACCESSORIES
K903027 · Pfizer Laser Systems · Oct 1990
CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER
K902534 · Pfizer Laser Systems · Sep 1990