FDA device listing
ACP-8,ACP-8R
FDA device listing 1623553064 · Topcon Healthcare, Inc.
Key facts
| Proprietary names | ACP-8,ACP-8R |
|---|---|
| Owner/operator | Topcon Healthcare, Inc. |
| Owner/operator number | 9031569 |
| Product codes | HOS |
| Device names | HOS - Projector, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1680 |
| Review panels | Ophthalmic |
| Registered establishments | TOPCON CORP., Topcon Yamagata Co., LTD, Topcon Yamagata Co., LTD West Factory |
| Establishment registrations | 9614661, 3002808383, 3008729548 |
| FEI numbers | 1000175127, 3002808383, 3008729548 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| 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