The following data is part of a premarket notification filed by Multi Radiance Medical with the FDA for Mr4 Laser.
| Device ID | K171354 |
| 510k Number | K171354 |
| Device Name: | MR4 Laser |
| 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 Pkwy 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 | 2017-05-09 |
| Decision Date | 2018-01-13 |