NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Novus Varia Ophthalmic Laser And Delivery Devices With Accessories.

Pre-market Notification Details

Device IDK022181
510k NumberK022181
Device Name:NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
ContactKaren L Baker
CorrespondentKaren L Baker
LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-03
Decision Date2002-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143736 K022181 000
07290109143729 K022181 000
07290109143668 K022181 000
07290109143392 K022181 000
07290109143385 K022181 000

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