FDA device listing
Lacriflow CL
FDA device listing 1996704147 · KANEKA CORP.
Key facts
| Proprietary names | Lacriflow CL |
|---|---|
| Owner/operator | KANEKA CORP. |
| Owner/operator number | 9005249 |
| Premarket submissions | K170247 |
| Product codes | OKS |
| Device names | OKS - Lacrimal Stents And Intubation Sets |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.OKS |
| Review panels | Ophthalmic |
| Registered establishments | Kaneka Corporation Osaka Plant, KANEKA MEDIX CORPORATION KANAGAWA PLANT |
| Establishment registrations | 9614654, 3009761573 |
| FEI numbers | 3002808904, 3009761573 |
| Establishment operations | Foreign Exporter, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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