ZEISS VISULAS ARGON LASER

Powered Laser Surgical Instrument

CARL ZEISS, INC.

The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Visulas Argon Laser.

Pre-market Notification Details

Device IDK923341
510k NumberK923341
Device Name:ZEISS VISULAS ARGON LASER
ClassificationPowered Laser Surgical Instrument
Applicant CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton,  NJ  08540
ContactChristopher Talbot
CorrespondentChristopher Talbot
CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton,  NJ  08540
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-05
Decision Date1992-10-28

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