35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM

Powered Laser Surgical Instrument

PFIZER LASER SYSTEMS

The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for 35 Watt Surgical Carbon Dioxide Laser System.

Pre-market Notification Details

Device IDK896049
510k NumberK896049
Device Name:35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant PFIZER LASER SYSTEMS 3 MORGAN Irvine,  CA  92718
ContactCozean, Phd
CorrespondentCozean, Phd
PFIZER LASER SYSTEMS 3 MORGAN Irvine,  CA  92718
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-18
Decision Date1990-01-11

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