FDA 510(k)

Acuity 181™ (tisilfocon A) et Acuity 181™ (tisilfocon A) avec Tangible™ Hydra-PEG® Lentille de Contact Rigid à Perte Gazeuse

Numéro K : K242393 · 2024-11-01

Date de décision2024-11-01

Code produitHQD

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Acuity Polymers, Inc. en tant que demandeur

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Dispositifs connexes (Code : HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight K240618Acuity 200™ (fluoroxyfocon A) Lentille de Contact Rigid à Pénétration Gazeuse; Acuity 100™ (hexafocon A) Lentille de Contact Rigid à Pénétration Gazeuse; Acuity 200™ avec Tangible® Hydra-PEG® (fluoroxyfocon A) Lentille de Contact Rigid à Pénétration Gazeuse; Acuity 100™ avec Tangible® Hydra-PEG® (hexafocon A) Lentille de Contact Rigid à Pénétration GazeuseAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC K230965Acuity 100™ (hexafocon A) avec Tangible™ Hydra-PEG®, TYRO™-97 (hexafocon A) avec Tangible™ Hydra-PEG® Lentille de Contact Rigid à Perte GazeuseAcuity Polymers, Inc.

Source officielle

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