FDA 510(k)

Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses

K-Number: K242393 · 2024-11-01

Decision Date2024-11-01

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses is a medical device manufactured by Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2024-11-01 under approval number K242393. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses?

Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Acuity Polymers, Inc.. The 510(k) number is K242393.

When was Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses approved by the FDA?

Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2024-11-01, under approval number K242393.

What company makes Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses?

Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses is manufactured by Acuity Polymers, Inc..

What is the FDA product code for Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses?

The FDA product code for Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses is HQD.

Related Clinical Trials

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Other Devices by Acuity Polymers, Inc.

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Related Devices (Code: HQD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.