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 IDK192430
510k NumberK192430
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-05
Decision Date2019-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00647529003817 K192430 000
00647529004166 K192430 000
00647529004159 K192430 000

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