ASA 'MPHI FAMILY DIODE LASER

Lamp, Infrared, Therapeutic Heating

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Asa 'mphi Family Diode Laser.

Pre-market Notification Details

Device IDK111901
510k NumberK111901
Device Name:ASA 'MPHI FAMILY DIODE LASER
ClassificationLamp, Infrared, Therapeutic Heating
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactAnthony Burns
CorrespondentAnthony Burns
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-05
Decision Date2011-11-09
Summary:summary

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