LaserShot M, NaviLase

System, Assisted Reproduction Laser

Vitrolife GmbH

The following data is part of a premarket notification filed by Vitrolife Gmbh with the FDA for Lasershot M, Navilase.

Pre-market Notification Details

Device IDK192008
510k NumberK192008
Device Name:LaserShot M, NaviLase
ClassificationSystem, Assisted Reproduction Laser
Applicant Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg,  DE 84079
ContactSusanne Schweitzer
CorrespondentSusanne Schweitzer
Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg,  DE 84079
Product CodeMRX  
CFR Regulation Number884.6200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260604170028 K192008 000
04260604170011 K192008 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.