FDA device listing
APH 550,MPH 150,Vision-R 700,Vision-R 800,Vision-S 700
FDA device listing 1041047800 · Essilor International
Key facts
| Proprietary names | APH 550,MPH 150,Vision-R 700,Vision-R 800,Vision-S 700 |
|---|---|
| Owner/operator | Essilor International |
| Owner/operator number | 10042939 |
| Product codes | HKN |
| Device names | HKN - Refractor, Manual, Non-Powered, Including Phoropter |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1770 |
| Review panels | Ophthalmic |
| Registered establishments | ESSILOR INTERNATIONAL- HQ, ESSILOR International Usine de la Compasserie |
| Establishment registrations | 3010227033 |
| FEI numbers | 3010227033 |
| Establishment operations | Foreign Private Label Distributor, 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