CYNOSURE PHOTOGENICA VLS-STAR

Powered Laser Surgical Instrument

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Photogenica Vls-star.

Pre-market Notification Details

Device IDK000490
510k NumberK000490
Device Name:CYNOSURE PHOTOGENICA VLS-STAR
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford,  MA  01824
ContactGeorge Cho
CorrespondentGeorge Cho
CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford,  MA  01824
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-15
Decision Date2000-03-13

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