Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

Laser, Ophthalmic

Lumenis Be, Inc.

The following data is part of a premarket notification filed by Lumenis Be, Inc. with the FDA for Selecta Duet Led, Digital Duet, Selecta Led Trio, Digital Trio Laser Systems.

Pre-market Notification Details

Device IDK220877
510k NumberK220877
Device Name:Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
ClassificationLaser, Ophthalmic
Applicant Lumenis Be, Inc. 1870 South Milestone Drive Salt Lake City,  UT  84104
ContactShlomit Segman
CorrespondentShlomit Segman
Lumenis Be, Inc. 1870 South Milestone Drive Salt Lake City,  UT  84104
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-07-15

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