ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-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 Orion Series Surgical Laser System (sl Seriesq-switched Nd:yag Configuration).

Pre-market Notification Details

Device IDK990718
510k NumberK990718
Device Name:ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
ClassificationPowered Laser Surgical Instrument
Applicant LASERSCOPE 3052 ORCHARD DR. San Jose,  CA  95134 -2011
ContactPaul H Hardiman
CorrespondentPaul H Hardiman
LASERSCOPE 3052 ORCHARD DR. San Jose,  CA  95134 -2011
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-04
Decision Date2000-03-08
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.