KTP/532 LASER

Laser For Gastro-urology Use

LASERSCOPE

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

Pre-market Notification Details

Device IDK873330
510k NumberK873330
Device Name:KTP/532 LASER
ClassificationLaser For Gastro-urology Use
Applicant LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara,  CA  95051
ContactRichard P Rudy
CorrespondentRichard P Rudy
LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara,  CA  95051
Product CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-19
Decision Date1987-11-18

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