Lucent : IPL

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

LUVO Medical Technologies, Inc.

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

Pre-market Notification Details

Device IDK193072
510k NumberK193072
Device Name:Lucent : IPL
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
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 CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-04
Decision Date2020-03-05

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