REVLITE Q-SWITCHED ND:YAG LASER SYSTEM

Powered Laser Surgical Instrument

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Revlite Q-switched Nd:yag Laser System.

Pre-market Notification Details

Device IDK133254
510k NumberK133254
Device Name:REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactHuda Yusuf
CorrespondentHuda Yusuf
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-22
Decision Date2014-03-05
Summary:summary

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