SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Selecta Family Of Ophithalmic Laser Systems.

Pre-market Notification Details

Device IDK081704
510k NumberK081704
Device Name:SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactTina Mayer
CorrespondentTina Mayer
LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-17
Decision Date2008-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143316 K081704 000
07290109143309 K081704 000
07290109143262 K081704 000
07290109143255 K081704 000
07290109145181 K081704 000
07290109143637 K081704 000

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