LaseMD LEO Laser System

Powered Laser Surgical Instrument

Lutronic Global

The following data is part of a premarket notification filed by Lutronic Global with the FDA for Lasemd Leo Laser System.

Pre-market Notification Details

Device IDK192331
501k NumberK192331
Device Name:LaseMD LEO Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Lutronic Global 19 Fortune Drive Billerica,  MA  01821
ContactJames Childs
CorrespondentJames Childs
Lutronic Global 19 Fortune Drive Billerica,  MA  01821
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-27
Decision Date2019-11-12

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