Epic Pro 940

Powered Laser Surgical Instrument

Biolase, Inc

The following data is part of a premarket notification filed by Biolase, Inc with the FDA for Epic Pro 940.

Pre-market Notification Details

Device IDK172771
510k NumberK172771
Device Name:Epic Pro 940
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-14
Decision Date2017-11-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00647529003558 K172771 000

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