CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER

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 P Pigmented Lesion Laser.

Pre-market Notification Details

Device IDK921841
510k NumberK921841
Device Name:CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 35 WIGGINS AVE. Bedford,  MA  01730 -2314
ContactGeorge Cho
CorrespondentGeorge Cho
CYNOSURE, INC. 35 WIGGINS AVE. Bedford,  MA  01730 -2314
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-17
Decision Date1992-08-04

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