FDA device listing
Avance,Crizal,Definity,DEFINITY 2,Essilor Ideal,Kodak,Optifog,Ovation,Presio i Approval,Sharpview,Small…
FDA device listing 1380202034 · Essilor of America, Inc
Key facts
| Proprietary names | Avance,Crizal,Definity,DEFINITY 2,Essilor Ideal,Kodak,Optifog,Ovation,Presio i Approval,Sharpview,Small Fit,Trivex,TruClear,Varilux,VARILUX-2,Xperio |
|---|---|
| Owner/operator | Essilor of America, Inc |
| Owner/operator number | 8010073 |
| Product codes | HQG |
| Device names | HQG - Lens, Spectacle, Non-Custom (Prescription) |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.5844 |
| Review panels | Ophthalmic |
| Registered establishments | BBGR, Distrilens, LLC, Essilor Asia Pacific PTE LTD, Essilor Da Amazonia Industria E Comercio, ESSILOR INTERNATIONAL, ESSILOR INTERNATIONAL, S.A., Essilor Lao Company Limited, Essilor Manufacturing India Private Limited, ESSILOR MANUFACTURING PHILIPPINES INC., ESSILOR MANUFACTURING (THAILAND) CO., LTD., Essilor Optical Laboratory (Thailand) Co., Ltd., ESSILOR TIJUANA OPTICA, S. DE R.L. DE C.V. and 10 more |
| Establishment registrations | 1215866, 1000178824, 1000378975, 1000431825, 3003291784, 3003320310, 3003325113, 3003748653, 3003803218, 3004052568, 3004110262, 3004573418, 3004741385, 3005674463, 3005728056, 3007529446, 3007817071, 3010625678, 3010910479, 3013532963 and 3 more |
| FEI numbers | 1215866, 1000178824, 1000378975, 1000431825, 3003291784, 3003320310, 3003325113, 3003748653, 3003803218, 3004052568, 3004110262, 3004573418, 3004741385, 3005674463, 3005728056, 3007529446, 3007817071, 3010625678, 3010910479, 3013532963 and 3 more |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| 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