Acuity Polymers, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas PermeaNovember 1, 2024
K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas April 3, 2024
K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® June 16, 2023
K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensDecember 30, 2021
K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensApril 9, 2021
K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensSeptember 8, 2020
K180988Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas PermeaJune 8, 2018
K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensJune 2, 2017
K170007Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensMay 31, 2017
K163254Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensJanuary 18, 2017
K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensDecember 8, 2016