LUMENIS 1000 INTEGRATED SLIT LAMP

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Lumenis 1000 Integrated Slit Lamp.

Pre-market Notification Details

Device IDK052129
510k NumberK052129
Device Name:LUMENIS 1000 INTEGRATED SLIT LAMP
ClassificationPowered Laser Surgical Instrument
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 CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-05
Decision Date2005-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143811 K052129 000
07290109143712 K052129 000

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