Multifrax Laser System

Powered Laser Surgical Instrument With Microbeam\fractional Output

Paradigm Medical Corporation

The following data is part of a premarket notification filed by Paradigm Medical Corporation with the FDA for Multifrax Laser System.

Pre-market Notification Details

Device IDK213332
510k NumberK213332
Device Name:Multifrax Laser System
ClassificationPowered Laser Surgical Instrument With Microbeam\fractional Output
Applicant Paradigm Medical Corporation 7371 Los Brazos San Diego,  CA  92127
ContactNikolai Tankovich
CorrespondentMaureen O'Connell
O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham,  MA  02180
Product CodeONG  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-06
Decision Date2022-06-03

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