Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens— 510(k) K240618

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K240618 for Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2024-04-03. Applicant: Acuity Polymers, Inc..

Clearance details

Applicant: Acuity Polymers, Inc.
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2024-03-05
Decision date: 2024-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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