Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954)
Description
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens by Innova Vision, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222954
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) C... | Innova Vision, Inc. | 2022 |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH... | Innova Vision, Inc. | 2009 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic)... | Innova Vision, Inc. | 2024 |
Trace the full predicate network for K222954
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.