FibroLux

Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

Multi Radiance Medical

The following data is part of a premarket notification filed by Multi Radiance Medical with the FDA for Fibrolux.

Pre-market Notification Details

Device IDK212189
510k NumberK212189
Device Name:FibroLux
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant Multi Radiance Medical 6521 Davis Industrial Parkway Solon,  OH  44139
ContactAndrey Godes
CorrespondentKevin Walls
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-13
Decision Date2022-09-02

Trademark Results [FibroLux]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIBROLUX
FIBROLUX
97583643 not registered Live/Pending
Medical Quant USA, Inc.
2022-09-08
FIBROLUX
FIBROLUX
79072137 not registered Dead/Abandoned
Eloesser, Michael
2008-08-12

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