Elite IQ

Powered Laser Surgical Instrument

Cynosure LLC

The following data is part of a premarket notification filed by Cynosure Llc with the FDA for Elite Iq.

Pre-market Notification Details

Device IDK193426
510k NumberK193426
Device Name:Elite IQ
ClassificationPowered Laser Surgical Instrument
Applicant Cynosure LLC 5 Carlisle Road Westford,  MA  01886
ContactMichael King
CorrespondentMichael King
Cynosure LLC 5 Carlisle Road Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-10
Decision Date2020-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08057017760467 K193426 000
08057017760450 K193426 000

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