ZEISS VISULAS ARGON LASER

Laser, Ophthalmic

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 IDK874609
510k NumberK874609
Device Name:ZEISS VISULAS ARGON LASER
ClassificationLaser, Ophthalmic
Applicant CARL ZEISS, INC. ONE ZEISS DR. Thornwood,  NY  10594
ContactVan Cader
CorrespondentVan Cader
CARL ZEISS, INC. ONE ZEISS DR. Thornwood,  NY  10594
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-09
Decision Date1988-01-06

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