FDA device listing
EVO VISIAN Implantable Collamer Lens,EVO+ VISIAN Implantable Collamer Lens,EVO VISIAN Toric Implantable Collamer…
FDA device listing 1829508920 · STAAR SURGICAL Company
Key facts
| Proprietary names | EVO VISIAN Implantable Collamer Lens,EVO+ VISIAN Implantable Collamer Lens,EVO VISIAN Toric Implantable Collamer Lens,EVO+ VISIAN Toric Implantable Collamer Lens,Implantable Collamer Lens |
|---|---|
| Owner/operator | STAAR SURGICAL Company |
| Owner/operator number | 2023826 |
| Premarket submissions | P030016 |
| Product codes | MTA, QCB |
| Device names | MTA - Lens, Intraocular, Phakic, QCB - Phakic Toric Intraocular Lens |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.3600, ORCA1.MTA |
| Review panels | Ophthalmic |
| Registered establishments | STAAR SURGICAL AG, STAAR Surgical Company, STAAR SURGICAL COMPANY |
| Establishment registrations | 2023826, 9614429, 3014173684 |
| FEI numbers | 2023826, 3002808259, 3014173684 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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