Elysion-pro

Powered Laser Surgical Instrument

High Technology Products SLU

The following data is part of a premarket notification filed by High Technology Products Slu with the FDA for Elysion-pro.

Pre-market Notification Details

Device IDK193367
510k NumberK193367
Device Name:Elysion-pro
ClassificationPowered Laser Surgical Instrument
Applicant High Technology Products SLU Pasaje Masoliver 24 Barcelona,  ES 08005
ContactSergi Lozano
CorrespondentVardhini Kirthivas
Freyr Global Regulatory Solutions And Services Level 4 Building No. H-08, Phoenix SEZ Phase 2 Gachibowli, Hyderabad,  IN 500081
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 Received2019-12-04
Decision Date2020-03-12

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