FDA device listing
3D Binocular Vision Technology,Accord,ACSCENT HD,ActV,AdaptEase Technology,ADVANTA,AF,AF 2,AF 2 MINI,AF…
FDA device listing 1152489170 · Hoya Optical Labs of America, Inc.
Key facts
| Proprietary names | 3D Binocular Vision Technology,Accord,ACSCENT HD,ActV,AdaptEase Technology,ADVANTA,AF,AF 2,AF 2 MINI,AF MINI,ALLIANCE,AMPIA,AMPIA HD,AMPIA HD SHORT,AMPIA SHORT,Amplitude,Amplitude BKS,Amplitude HD3,Amplitude HD3 Mini,Amplitude HiDef,Amplitude iQ,Amplitude Mini BKS,Amplitude Mini HiDef,Amplitude Mini iQ,Amplitude Poly Lens,AR3,ARGOS SHORT,ARRAY 11,ARRAY 13,ARRAY 15,ARRAY 17,ARRAY II 11,ARRAY II… |
|---|---|
| Owner/operator | Hoya Optical Labs of America, Inc. |
| Owner/operator number | 8030208 |
| 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 | DAEJEON DAEMYUNG OPTICAL CO., LTD, EHS Lens Philippines, Inc Batangas Plant, Hoya Corporation Vision Care Section, Hoya Lens Canada, Inc., HOYA LENS THAILAND LTD., HOYA LENS VIETNAM LTD, HOYA LENS VIETNAM, LTD. - QUANG NGAI BRANCH, Hoya Optical Labs of America Inc., HOYA OPTICAL LABS OF AMERICA, INC., Hoya Vision Care - Atlanta, Hoya Vision Care Boise, Hoya Vision Care - Chicago and 11 more |
| Establishment registrations | 1651901, 2124545, 8040222, 3003324653, 3003367816, 3004551316, 3004907366, 3005128535, 3005502151, 3005693266, 3006378871, 3006384133, 3006575381, 3007581768, 3007710584, 3007793463, 3007793466, 3007829487, 3009352545, 3011518249 and 4 more |
| FEI numbers | 2124545, 3002862799, 3003324653, 3003367816, 3004551316, 3004836791, 3004907366, 3005128535, 3005502151, 3005693266, 3006378871, 3006384133, 3006575381, 3007581768, 3007710584, 3007793463, 3007793466, 3007829487, 3009352545, 3011518249 and 4 more |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, 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