VISULAS Green

Laser, Ophthalmic

Carl Zeiss Meditec AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visulas Green.

Pre-market Notification Details

Device IDK181682
510k NumberK181682
Device Name:VISULAS Green
ClassificationLaser, Ophthalmic
Applicant Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena,  DE 07445
ContactChristian Munster
CorrespondentLisa Graney
Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-26
Decision Date2019-03-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049471091441 K181682 000
04049471091434 K181682 000
04049471091427 K181682 000
04049471091410 K181682 000

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