ACCOLADE II LASER

Powered Laser Surgical Instrument

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Accolade Ii Laser.

Pre-market Notification Details

Device IDK072868
510k NumberK072868
Device Name:ACCOLADE II LASER
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactGeorge Cho
CorrespondentGeorge Cho
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-09
Decision Date2007-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494100100 K072868 000

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