Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (K242393)
Description
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses by Acuity Polymers, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242393
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. Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (K242393) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact L... | Acuity Polymers, Inc. | 2024 |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, rofluf... | Visionary Optics, LLC | 2022 |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Contamac, Ltd. | 2018 |
Trace the full predicate network for K242393
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.