FDA device listing
Laser Shower LS50,LS50 Emitter,MR4 Activ,MR4 Laser,MR4 LaserShower 50 4-D Emitter,MR4 LaserStim Emitter,MR4 Se 25…
FDA device listing 1466995438 · Multi Radiance Medical
Key facts
| Proprietary names | Laser Shower LS50,LS50 Emitter,MR4 Activ,MR4 Laser,MR4 LaserShower 50 4-D Emitter,MR4 LaserStim Emitter,MR4 Se 25 Laser,MR4 SE25 Standard Emitter,MR4 Super Pulsed Laser,MR4 Ultra,PainAway,TQ Solo |
|---|---|
| Owner/operator | Multi Radiance Medical |
| Owner/operator number | 9087202 |
| Premarket submissions | K080102 |
| Product codes | GEX, ILY |
| Device names | GEX - Powered Laser Surgical Instrument, ILY - Lamp, Infrared, Therapeutic Heating |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810, 890.5500 |
| Review panels | General & Plastic Surgery, Physical Medicine |
| Registered establishments | MEDICAL QUANT USA, MILTA PKP-GIT |
| Establishment registrations | 3005730446, 3005739661 |
| FEI numbers | 3005730446, 3005739661 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database