FDA 510(k)

Acuity 181™ (티실로콘 A) 및 Acuity 181™ (티실로콘 A)와 Tangible™ Hydra-PEG® 고정형 가스 투과성隐形眼镜

K-번호: K242393 · 2024-11-01

결정일2024-11-01

제품 코드HQD

자문 위원회OP

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K242393.

When did Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses receive FDA 510(k) clearance?

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 510(k) number K242393.

Who is the listed applicant for Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses?

The FDA 510(k) record lists Acuity Polymers, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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