Leaseir MHR Xcell

Powered Laser Surgical Instrument

Leaseir Technologies S.L.U.

The following data is part of a premarket notification filed by Leaseir Technologies S.l.u. with the FDA for Leaseir Mhr Xcell.

Pre-market Notification Details

Device IDK214049
510k NumberK214049
Device Name:Leaseir MHR Xcell
ClassificationPowered Laser Surgical Instrument
Applicant Leaseir Technologies S.L.U. C/ Jimena Fernández De La Vega, 140 1ºH Gijón,  ES 33203
ContactPablo Boto
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-06-02

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