EPIC 10

Powered Laser Surgical Instrument

BIOLASE TECHNOLOGY, INC.

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

Pre-market Notification Details

Device IDK121286
510k NumberK121286
Device Name:EPIC 10
ClassificationPowered Laser Surgical Instrument
Applicant BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine,  CA  92618 -1816
ContactRobert Yang
CorrespondentRobert Yang
BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine,  CA  92618 -1816
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-30
Decision Date2012-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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