LASERTRIPTER MINISCOPE

Mini Endoscope, Gastroenterology-urology

CANDELA LASER CORP.

The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Lasertripter Miniscope.

Pre-market Notification Details

Device IDK874858
510k NumberK874858
Device Name:LASERTRIPTER MINISCOPE
ClassificationMini Endoscope, Gastroenterology-urology
Applicant CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactGeorge Cho
CorrespondentGeorge Cho
CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
Product CodeODF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-25
Decision Date1988-02-19

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