FDA device listing
AMARA CONTACT LENS,Amara Lens,Another Me Kristin,Attention-Plz Kristin,Barris Land,Day n' Night Kristin,Debut…
FDA device listing 1332231561 · VISION SCIENCE CO., LTD.
Key facts
| Proprietary names | AMARA CONTACT LENS,Amara Lens,Another Me Kristin,Attention-Plz Kristin,Barris Land,Day n' Night Kristin,Debut Kristin,Dimple Color,Dimplecolor 1-day colour lenses,Dimple Color Colour Lenses,Dimple Color Contact Lenses,Doll Nikita,Eyereve Colors 1-day,Grrrr Kristin,Hapa Kristin Colored Contact Lenses,Hapa Kristin Colored Contacts,Hapa Kristin Colored Lenses,Hapa Kristin Contact Lenses,Hapa Kristin… |
|---|---|
| Owner/operator | VISION SCIENCE CO., LTD. |
| Owner/operator number | 10046391 |
| Premarket submissions | K161124 |
| Product codes | LPL, MVN |
| Device names | LPL - Lenses, Soft Contact, Daily Wear, MVN - Lens, Contact, (Disposable) |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.5925 |
| Review panels | Ophthalmic |
| Registered establishments | VISION SCIENCE CO., LTD. |
| Establishment registrations | 3006946962 |
| FEI numbers | 3006946962 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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