FDA device listing
B170 motor set,B350D motor set,E-cube EM type Motor set,FUE straight handpiece Strong AT-II
FDA device listing 1003448057 · Saeshin Precision Co., Ltd.
Key facts
| Proprietary names | B170 motor set,B350D motor set,E-cube EM type Motor set,FUE straight handpiece Strong AT-II |
|---|---|
| Owner/operator | Saeshin Precision Co., Ltd. |
| Owner/operator number | 10030579 |
| Product codes | GEY |
| Device names | GEY - Motor, Surgical Instrument, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SAESHIN PRECISION CO., LTD. |
| Establishment registrations | 3007958831 |
| FEI numbers | 3007958831 |
| Establishment operations | 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