FDA device listing
A-100 LASERwrap® System, Class 1M Laser 600nm (Non-IR), Patented,Slim A-10 LASERwrap® System, Class 1M Laser 660nm…
FDA device listing 2057776074 · Spectra Therapy LLC
Key facts
| Proprietary names | A-100 LASERwrap® System, Class 1M Laser 600nm (Non-IR), Patented,Slim A-10 LASERwrap® System, Class 1M Laser 660nm (Non-IR), Patented |
|---|---|
| Owner/operator | Spectra Therapy LLC |
| Owner/operator number | 10050541 |
| Product codes | ILY |
| Device names | ILY - Lamp, Infrared, Therapeutic Heating |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5500 |
| Review panels | Physical Medicine |
| Registered establishments | SPECTRA THERAPY LLC |
| Establishment registrations | 3008539245 |
| FEI numbers | 3008539245 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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