MODEL VISULAS 532S LASER WITH THE VITE OPTION

Powered Laser Surgical Instrument

CARL ZEISS MEDITEC AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Model Visulas 532s Laser With The Vite Option.

Pre-market Notification Details

Device IDK100035
510k NumberK100035
Device Name:MODEL VISULAS 532S LASER WITH THE VITE OPTION
ClassificationPowered Laser Surgical Instrument
Applicant CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactJudith A Brimacombe
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-01-06
Decision Date2010-03-17
Summary:summary

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