SCANNING LASERLINK

Laser, Ophthalmic

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Scanning Laserlink.

Pre-market Notification Details

Device IDK130195
510k NumberK130195
Device Name:SCANNING LASERLINK
ClassificationLaser, Ophthalmic
Applicant LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactJace R Mclane
CorrespondentJace R Mclane
LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-28
Decision Date2013-11-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143545 K130195 000

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