VISULAS YAG II

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 Visulas Yag Ii.

Pre-market Notification Details

Device IDK003885
510k NumberK003885
Device Name:VISULAS YAG II
ClassificationPowered Laser Surgical Instrument
Applicant CARL ZEISS, INC. ONE ZEISS DR. Thornwood,  NY  10594
ContactScott A Margolin
CorrespondentScott A Margolin
CARL ZEISS, INC. ONE ZEISS DR. Thornwood,  NY  10594
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-15
Decision Date2001-02-22

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