OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (K241707)
Description
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ by Unicon Optical Co., Ltd., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241707
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. OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (K241707) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) C... | Innova Vision, Inc. | 2022 |
| K213216 | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact... | Unicon Optical Co., Ltd. | 2022 |
| K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact ... | Unicon Optical Co., Ltd. | 2019 |
Trace the full predicate network for K241707
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.