LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS

Powered Laser Surgical Instrument

LUMENIS, LTD.

The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Lumenis Family Of Ipl Systems And Combination Ipl/nd:yag Systems.

Pre-market Notification Details

Device IDK030342
510k NumberK030342
Device Name:LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara,  CA  95051
ContactAndrea L Ruth
CorrespondentAndrea L Ruth
LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara,  CA  95051
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-03
Decision Date2003-07-17
Summary:summary

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