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Sign in to claim this brandMulti Radiance Medical
United States·US-MF-000032709
Last updated September 18, 2026
About
Laser treatment is a non-invasive and side effect free method to help reduce acute and chronic pain. An FDA cleared alternative to pain medications or potential surgery. Laser treatments take just minutes a day, depending on the condition being treated, and can easily be done in the comfort of your own home. Multi Radiance Medical laser technology has been used safely and effectively among a wide range of patient populations for years in: physical therapy, orthopedics, outpatient clinics, and chiropractic offices, as well as with elite athletics for numerous national, professional and collegiate teams worldwide. Portable models you can take for pain relief anywhere, anytime.
From the manufacturer's own website. Source
What Multi Radiance Medical makes
Multi Radiance Medical produces non-wearable infrared phototherapy units designed for musculoskeletal applications, including devices like the MR5 Activ Pro, PainAway, and FibroLux. These units are intended for pain relief and tissue healing, targeting conditions such as acute and chronic musculoskeletal pain, with some models also used in physical therapy and athletic recovery settings. The portfolio includes both stationary and portable units for in-clinic or home use.
The company’s devices fall under FDA Class II and Class IIa classifications, with some entries listed in the EU’s eudamed registry alongside FDA 510(k) and UDI registrations. The manufacturer is based in the United States, adhering to regulatory requirements for medical devices in both domestic and international markets.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of medical devices does Multi Radiance Medical manufacture?
Multi Radiance Medical manufactures non-wearable infrared phototherapy units designed for musculoskeletal applications. These devices are intended for pain relief and tissue healing, targeting acute and chronic musculoskeletal pain, and are used in settings such as physical therapy, orthopedics, outpatient clinics, chiropractic offices, and athletic recovery. Examples include the MR5 Activ Pro, PainAway, MR4, TerraQuant, and FibroLux models. The company does not produce wearable devices or products outside this category based on the provided data.
Where is Multi Radiance Medical based?
Multi Radiance Medical is based in the United States. This is explicitly stated in the device data under the COUNTRY field, which identifies the company’s location as US. The company adheres to regulatory requirements for medical devices in both domestic U.S. markets and international markets, as noted in the summary, but no further details about specific facilities, headquarters address, or staffing are provided in the source material.
In which regulatory registries are Multi Radiance Medical's devices listed?
Multi Radiance Medical's devices are listed in the EUDAMED registry, the FDA 510(k) database, and the FDA UDI (Unique Device Identification) system. These registries are explicitly named in the LISTED IN field of the device data. Inclusion in these systems indicates that the company’s devices have undergone regulatory scrutiny for market access in the United States and the European Union, though individual device authorizations—not the company itself—are what are cleared or registered.
How are Multi Radiance Medical's devices classified under regulatory frameworks?
Multi Radiance Medical's devices are classified as Class II under the U.S. FDA system and Class IIa under the European Union’s medical device classification framework. This dual classification is specified in the DEVICE CLASSES field, which lists both Class II and Class IIa. These classifications indicate moderate risk, requiring special controls such as performance standards, post-market surveillance, and labeling requirements, but do not imply that the company as a whole is approved or certified—only that individual devices meet the criteria for these classes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6521, Davis Industrial Parkway, Solon, United States
- Website
- multiradiance.com
- facebook.com/multiradiance
- [email protected]
- Phone
- +1-440-542-0761
- PRRC Contact
- Andrey Godes
- EUDAMED SRN
- US-MF-000032709
- FDA FEI Number
- —
- DUNS Number
- 826320694
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MR5 Activ Pro | K254024 | FDA 510(k) | Class II | Active |
| PainAway | PainAway | FDA UDI | Class II | Active |
| Mr4 | MR4 Laser System G | FDA UDI | Class II | Active |
| Mr5 | MR5 Activ Pro | FDA UDI | Class II | Active |
| Mr4 | MR4 Activ G | FDA UDI | Class II | Active |
| Painaway | PainAway Homecare | FDA UDI | Class II | Active |
| TerraQuant | TQ LaserStim Emitter | FDA UDI | Class II | Active |
| Mr4 | MR4 Super Pulsed Laser Console G | FDA UDI | Class II | Active |
| TerraQuant | TQ LaserShower 50 4-D Emitter | FDA UDI | Class II | Active |
| FibroLux | FibroLux | FDA UDI | Class II | Active |
| Mr5 | MR5 Activ Pro LaserStim G | FDA UDI | Class II | Active |
| PainAway | PainAway PostOp Laser | FDA UDI | Class II | Active |
| SportLaser | SportLaser | FDA UDI | Class II | Active |
| Mr4 | MR4 Activ | FDA UDI | Class II | Active |
| TerraQuant | TQ Solo Laser | FDA UDI | Class II | Active |
| TruDenta | TruDenta Laser System | FDA UDI | Class II | Active |
| Painaway | PainAway | FDA UDI | Class II | Active |
| Mr4 | MR4 Laser System | FDA UDI | Class II | Active |
| PainAway | PainAway Home Care | FDA UDI | Class II | Active |
| Mr4 | MR4 LaserStim Emitter | FDA UDI | Class II | Active |
| GameDay | Gameday Laser | FDA UDI | Class II | Active |
| Mr5 | MR5 Activ Pro Laser Shower | FDA UDI | Class II | Active |
| Mr5 | MR5 Activ Pro G | FDA UDI | Class II | Active |
| TerraQuant | TerraQuant Super Pulsed Laser Console | FDA UDI | Class II | Active |
| PainCure | PainCure | FDA UDI | Class II | Active |
| TerraQuant | TQ SE25 Standard Emitter | FDA UDI | Class II | Active |
| Mr5 | MR5 Activ Pro LaserStim | FDA UDI | Class II | Active |
| Mr4 | MR4 LaserStim Emitter G | FDA UDI | Class II | Active |
| Mr4 | MR4 LaserShower 50 4-D Emitter G | FDA UDI | Class II | Active |
| Mr4 | MR4 LaserShower 50 6-D Emitter | FDA UDI | Class II | Active |
| GameDay | Gameday Laser | FDA UDI | Class II | Active |
| GameDay | Gameday Laser | FDA UDI | Class II | Active |
| GameDay | Gameday Laser G | FDA UDI | Class II | Active |
| Mr5 | MR5 Activ Pro Laser Shower G | FDA UDI | Class II | Active |
| TerraQuant | TerraQuant Laser System | FDA UDI | Class II | Active |
| FibroLux | K212189 | FDA 510(k) | Class II | Active |
| TQ Solo Laser | 800-300 | EUDAMEDFDA UDI | Class IIa | Active |
| MR4 Super Pulsed Laser | 600 | EUDAMEDFDA UDI | Class IIa | Active |
| MR4 SE25 Standard Emitter | 650-113 | EUDAMEDFDA UDI | Class IIa | Active |
| MR4 LaserShower 50 4-D Emitter | 650-114 | EUDAMEDFDA UDI | Class IIa | Active |
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