COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Laserlink Z-1000 Slit Lamp Laser Delivery Adapter.

Pre-market Notification Details

Device IDK000498
510k NumberK000498
Device Name:COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
ContactEdward C Yu
CorrespondentEdward C Yu
LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-15
Decision Date2000-03-13

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