Primelase Excellence

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 Primelase Excellence.

Pre-market Notification Details

Device IDK201594
510k NumberK201594
Device Name:Primelase Excellence
ClassificationPowered Laser Surgical Instrument
Applicant High Technology Products SLU Pasaje Masoliver 24 Barcelona,  ES 08005
ContactSergi Lozano
CorrespondentVardhini Kirthivas
Freyr Global Regulatory Solutions & 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 Received2020-06-12
Decision Date2020-12-17

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