FDA device listing
Elantra,Escape,Etna,Laguna Edge (2M),Laguna Mist 29,Laguna Mist 32,Laguna Nigel 2011,Laguna Sand 30,Laguna Sand…
FDA device listing 1361736897 · Silhouet-Tone Corporation
Key facts
| Proprietary names | Elantra,Escape,Etna,Laguna Edge (2M),Laguna Mist 29,Laguna Mist 32,Laguna Nigel 2011,Laguna Sand 30,Laguna Sand SBF-4C,Nevada Electric 4C/30,Nevada Electric 4C/32,Nevada Electric Cabinet,Newstream massage table 4 Cushions,NewStream Serenity Table,Serenity SBF-4c,Spa One |
|---|---|
| Owner/operator | Silhouet-Tone Corporation |
| Owner/operator number | 8020371 |
| Product codes | LGX |
| Device names | LGX - Table, Examination, Medical, Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4960 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SILHOUET-TONE CORPORATION, SILHOUET-TONE USA |
| Establishment registrations | 1225072, 3005545844 |
| FEI numbers | 3000205157, 3005545844 |
| 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