FDA device listing
Elite Bronze,Elite Bronze Double Hydraulic,Elite Platinum,Elite series MD-100,Elite Silver Star,Laguna Mist Flex with…
FDA device listing 1693620608 · Silhouet-Tone Corporation
Key facts
| Proprietary names | Elite Bronze,Elite Bronze Double Hydraulic,Elite Platinum,Elite series MD-100,Elite Silver Star,Laguna Mist Flex with armrest |
|---|---|
| Owner/operator | Silhouet-Tone Corporation |
| Owner/operator number | 8020371 |
| Product codes | GBB |
| Device names | GBB - Chair, Surgical, Ac-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