Epic 980

Powered Laser Surgical Instrument

Biolase, Inc

The following data is part of a premarket notification filed by Biolase, Inc with the FDA for Epic 980.

Pre-market Notification Details

Device IDK193486
510k NumberK193486
Device Name:Epic 980
ClassificationPowered Laser Surgical Instrument
Applicant Biolase, Inc 4 Cromwell Irvine,  CA  92618
ContactAlicia Mszyca
CorrespondentAlicia Mszyca
Biolase, Inc 4 Cromwell Irvine,  CA  92618
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-03-16

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