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 ID | K212189 |
| 510k Number | K212189 |
| Device Name: | FibroLux |
| Classification | Powered 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 |
| Contact | Andrey Godes |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-13 |
| Decision Date | 2022-09-02 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852556007008 | K212189 | 000 |
Trademark Results [FibroLux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBROLUX 97583643 not registered Live/Pending |
Medical Quant USA, Inc. 2022-09-08 |
 FIBROLUX 79072137 not registered Dead/Abandoned |
Eloesser, Michael 2008-08-12 |
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