FDA device listing
Presio i Approval
FDA device listing 1857335432 · Essilor of America, Inc
Key facts
| Proprietary names | Presio i Approval |
|---|---|
| Owner/operator | Essilor of America, Inc |
| Owner/operator number | 8010073 |
| Product codes | NJH |
| Device names | NJH - Lens, Spectacle (Prescription), For Reading Discomfort |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.5844 |
| Review panels | Ophthalmic |
| Registered establishments | BBGR, Essilor Asia Pacific PTE LTD, Essilor Canada, ESSILOR INTERNATIONAL, ESSILOR INTERNATIONAL, S.A., Essilor Laboratories of America, Inc. dba Omega Northcreek Lab, ESSILOR MANUFACTURING (THAILAND) CO., LTD., Essilor Optical Laboratory (Thailand) Co., Ltd., Essilor Tijuana Optica, Fabris Lane Eyewear (Wenzhou) LTD, Nikon Optical Canada, Inc., Polinelli S.r.l. and 2 more |
| Establishment registrations | 1000178824, 1000431825, 3003291784, 3003325113, 3003748653, 3004104721, 3004110262, 3004573418, 3005674463, 3007529446, 3007817071, 3008853323, 3012433574, 3013532963, 3038269608 |
| FEI numbers | 1000178824, 1000431825, 3003291784, 3003325113, 3003748653, 3004104721, 3004110262, 3004573418, 3005674463, 3007529446, 3007817071, 3008853323, 3012433574, 3013532963, 3038269608 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 10–99 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