CENTAURI YAG LASER SYST, OPHTHAMOLOGY

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 Centauri Yag Laser Syst, Ophthamology.

Pre-market Notification Details

Device IDK904630
510k NumberK904630
Device Name:CENTAURI YAG LASER SYST, OPHTHAMOLOGY
ClassificationPowered Laser Surgical Instrument
Applicant PFIZER LASER SYSTEMS 3 MORGAN Irvine,  CA  92718
ContactCozean, Ph.d
CorrespondentCozean, Ph.d
PFIZER LASER SYSTEMS 3 MORGAN Irvine,  CA  92718
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-09
Decision Date1990-12-17

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