FDA 510(k)

Acuity 200 avec Tangible Hydra-PEG (fluoroxyfocon A) Lentille de Contact Rigid à Pénétration Gazeuse

Numéro K : K213538 · 2021-12-30

Date de décision2021-12-30

Code produitHQD

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens 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 2021-12-30 under 510(k) number K213538. 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 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K213538.

When did Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2021-12-30, under 510(k) number K213538.

Who is the listed applicant for Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

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 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens 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.K242393Acuity 181™ (tisilfocon A) et Acuity 181™ (tisilfocon A) avec Tangible™ Hydra-PEG® Lentille de Contact Rigid à Perte GazeuseAcuity Polymers, Inc.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

Source officielle

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