EPIC 10

Powered Laser Surgical Instrument

BIOLASE, INC.

The following data is part of a premarket notification filed by Biolase, Inc. with the FDA for Epic 10.

Pre-market Notification Details

Device IDK140120
510k NumberK140120
Device Name:EPIC 10
ClassificationPowered Laser Surgical Instrument
Applicant BIOLASE, INC. 4 CROMWELL Irvine,  CA  92618
ContactColleen Boswell
CorrespondentColleen Boswell
BIOLASE, INC. 4 CROMWELL Irvine,  CA  92618
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-16
Decision Date2014-10-10
Summary:summary

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