KTP/532 AND KTP/YAG

Powered Laser Surgical Instrument

LASERSCOPE

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

Pre-market Notification Details

Device IDK913758
510k NumberK913758
Device Name:KTP/532 AND KTP/YAG
ClassificationPowered Laser Surgical Instrument
Applicant LASERSCOPE 3052 ORCHARD DR. San Jose,  CA  95134 -2011
ContactDonna Page
CorrespondentDonna Page
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 Received1991-08-22
Decision Date1991-11-20

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