LISA Laser Surgical Fibers

Powered Laser Surgical Instrument

Omni-Guide Holdings, Inc.

The following data is part of a premarket notification filed by Omni-guide Holdings, Inc. with the FDA for Lisa Laser Surgical Fibers.

Pre-market Notification Details

Device IDK220189
510k NumberK220189
Device Name:LISA Laser Surgical Fibers
ClassificationPowered Laser Surgical Instrument
Applicant Omni-Guide Holdings, Inc. 46 Manning Road Billerica,  MA  01821
ContactCarlos O Acosta
CorrespondentCarlos O Acosta
Omni-Guide Holdings, Inc. 46 Manning Road Billerica,  MA  01821
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-24
Decision Date2022-04-29

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