KTP/YAG(TM) SURGICAL LASER

Powered Laser Surgical Instrument

LASERSCOPE

The following data is part of a premarket notification filed by Laserscope with the FDA for Ktp/yag(tm) Surgical Laser.

Pre-market Notification Details

Device IDK882734
510k NumberK882734
Device Name:KTP/YAG(TM) SURGICAL LASER
ClassificationPowered Laser Surgical Instrument
Applicant LASERSCOPE 3052 ORCHARD DR. San Jose,  CA  95134 -2011
ContactRichard P Rudy
CorrespondentRichard P Rudy
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 Received1988-07-01
Decision Date1988-09-09

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