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Acuity Polymers, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories1
Latest FDA decision2024-11-01
TypeNumberDevice NameCodeDateActions
510(k) K242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesHQD2024-11-01 View
510(k) K240618 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 LensHQD2024-04-03 View
510(k) K230965 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensHQD2023-06-16 View
510(k) K213538 Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD2021-12-30 View
510(k) K203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD2021-04-09 View
510(k) K201194 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD2020-09-08 View
510(k) K180988 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensHQD2018-06-08 View
510(k) K170001 Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensHQD2017-06-02 View
510(k) K170007 Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensHQD2017-05-31 View
510(k) K163254 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensHQD2017-01-18 View
510(k) K162005 Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensHQD2016-12-08 View
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