KTP/532 LASER FOR OB-GYN USE

Laser, Surgical, Gynecologic

LASERSCOPE

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

Pre-market Notification Details

Device IDK874837
510k NumberK874837
Device Name:KTP/532 LASER FOR OB-GYN USE
ClassificationLaser, Surgical, Gynecologic
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 CodeHHR  
CFR Regulation Number884.4550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-24
Decision Date1988-03-14

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