DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT

Powered Laser Surgical Instrument

LASERSCOPE

The following data is part of a premarket notification filed by Laserscope with the FDA for Dermastat, Micronspot, Macrospot, Focalstat.

Pre-market Notification Details

Device IDK950662
510k NumberK950662
Device Name:DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT
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 Received1995-02-13
Decision Date1995-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.