Pentacam AXL Wave

Device, Analysis, Anterior Segment

OCULUS Optikgerate GmbH

The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Pentacam Axl Wave.

Pre-market Notification Details

Device IDK201724
510k NumberK201724
Device Name:Pentacam AXL Wave
ClassificationDevice, Analysis, Anterior Segment
Applicant OCULUS Optikgerate GmbH Munchholzhauser StraBe 29 Wetzlar,  DE 35582
ContactEckhard Loh
CorrespondentRandy Prebula
Hogan Lovells, US LLP 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeMXK  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2020-10-21

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