FDA device listing
CLER ORTHOCYL OVERNIGHT LENS,GOV OVERNIGHT ORTHO-K LENS,KEEN Ortho-K OVERNIGHT LENS,RG5 OVERNIGHT ORTHO-K LENS
FDA device listing 2064534478 · Cler Vision Inc.
Key facts
| Proprietary names | CLER ORTHOCYL OVERNIGHT LENS,GOV OVERNIGHT ORTHO-K LENS,KEEN Ortho-K OVERNIGHT LENS,RG5 OVERNIGHT ORTHO-K LENS |
|---|---|
| Owner/operator | Cler Vision Inc. |
| Owner/operator number | 10094772 |
| Product codes | NUU |
| Device names | NUU - Lens, Contact, Orthokeratology, Overnight |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.5916 |
| Review panels | Ophthalmic |
| Registered establishments | CLER VISION INC. |
| Establishment registrations | 3022988037 |
| FEI numbers | 3022988037 |
| Establishment operations | Contract 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