KTP/532 SURGICAL LASER

Powered Laser Surgical Instrument

LASERSCOPE

The following data is part of a premarket notification filed by Laserscope with the FDA for Ktp/532 Surgical Laser.

Pre-market Notification Details

Device IDK884029
510k NumberK884029
Device Name:KTP/532 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 Received1988-09-23
Decision Date1988-11-25

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