LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)

Powered Laser Surgical Instrument

LASERSCOPE

The following data is part of a premarket notification filed by Laserscope with the FDA for Lyra G Series Surgical Laser System (sl Series Q-switched Nd:yag Configuration).

Pre-market Notification Details

Device IDK010284
510k NumberK010284
Device Name:LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
ClassificationPowered Laser Surgical Instrument
Applicant LASERSCOPE 3070 ORCHARD DR. San Jose,  CA  95134 -2011
ContactPaul H Hardiman
CorrespondentPaul H Hardiman
LASERSCOPE 3070 ORCHARD DR. San Jose,  CA  95134 -2011
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-31
Decision Date2001-05-01

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