FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES

Laser, Ophthalmic

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Family Of Selecta Ophthalmic Laser Systems (selecta 1064, Selecta Slt, Selecta Duo), Delivery Device And Accessories.

Pre-market Notification Details

Device IDK051944
510k NumberK051944
Device Name:FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
ClassificationLaser, Ophthalmic
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 CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-18
Decision Date2005-09-30
Summary:summary

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