LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES

Powered Laser Surgical Instrument

LASERSCOPE

The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope Vela Erbium:yag Laser System And Accessories.

Pre-market Notification Details

Device IDK971843
510k NumberK971843
Device Name:LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
ClassificationPowered Laser Surgical Instrument
Applicant LASERSCOPE 3052 ORCHARD DR. San Jose,  CA  95134 -2011
ContactLisa Mcgrath
CorrespondentLisa Mcgrath
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 Received1997-05-14
Decision Date1997-07-23
Summary:summary

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