Bare: 808

Powered Laser Surgical Instrument

LUVO Medical Technologies, Inc

The following data is part of a premarket notification filed by Luvo Medical Technologies, Inc with the FDA for Bare: 808.

Pre-market Notification Details

Device IDK193446
510k NumberK193446
Device Name:Bare: 808
ClassificationPowered Laser Surgical Instrument
Applicant LUVO Medical Technologies, Inc 125 Fleming Dr Cambridge,  CA N1t 2b8
ContactGregory Berzak
CorrespondentGregory Berzak
LUVO Medical Technologies, Inc 125 Fleming Dr Cambridge,  CA N1t 2b8
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-12
Decision Date2020-03-10

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