FDA device listing
Aquacolor Dailies Contact Lens,Aquacolor Premium Monthly Contact Lens,Aqualens Dailies Disposable Contact Lens,Bella…
FDA device listing 1987731101 · INTEROJO INC.
Key facts
| Proprietary names | Aquacolor Dailies Contact Lens,Aquacolor Premium Monthly Contact Lens,Aqualens Dailies Disposable Contact Lens,Bella Color Toric Hydrogel Daily (Methafilcon) Contact Lenses,Bella One Day Color Lenses,BELLA ONE DAY COLOR (Methafilcon) Contact Lenses,Celena Dailies,Clalen Iris,Comfort Colors,Crystal Vision Morning 55,DYE-Dress Your Eyes (Oneday Color Contact Lenses) (Methafilcon),FLAAK,Hapa Kristin… |
|---|---|
| Owner/operator | INTEROJO INC. |
| Owner/operator number | 9058386 |
| Premarket submissions | K142766 |
| 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 | INTEROJO INC. |
| Establishment registrations | 3004146030 |
| FEI numbers | 3004146030 |
| 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