Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens— 510(k) K230965

Substantially Equivalent

Acuity Polymers, Inc.

FDA 510(k) clearance K230965 for Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2023-06-16. Applicant: Acuity Polymers, Inc..

Clearance details

Applicant
Acuity Polymers, Inc.
Product code
Code HQD
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
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