Beacon Advanced CO2 Laser System

Powered Laser Surgical Instrument

OmniGuide, Inc

The following data is part of a premarket notification filed by Omniguide, Inc with the FDA for Beacon Advanced Co2 Laser System.

Pre-market Notification Details

Device IDK180993
510k NumberK180993
Device Name:Beacon Advanced CO2 Laser System
ClassificationPowered Laser Surgical Instrument
Applicant OmniGuide, Inc 4 Maguire Road Lexington,  MA  02421
ContactSam Wade
CorrespondentSam Wade
OmniGuide, Inc 4 Maguire Road Lexington,  MA  02421
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-16
Decision Date2018-06-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852306007715 K180993 000

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