Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES

Powered Laser Surgical Instrument

LUMENIS, LTD.

The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Q-switched Nd:yag Laser Treatment Head For The Lumenis Quantum Series.

Pre-market Notification Details

Device IDK043173
510k NumberK043173
Device Name:Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara,  CA  95051
ContactMartha Murari
CorrespondentMartha Murari
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 Received2004-11-16
Decision Date2005-01-31
Summary:summary

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