Acuity Polymers, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Acuity Polymers, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses, Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
11
Total
11
Cleared
0
Denied
Acuity Polymers, Inc. has 11 FDA 510(k) cleared ophthalmic devices. Based in Rochester, US.
Latest FDA clearance: Nov 2024. Active since 2016.
Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Eyereg Consulting, Inc. and Andre Vision and Device Research. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Acuity Polymers, Inc.
11 devices
Cleared
Nov 01, 2024
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™...
Ophthalmic
80d
Cleared
Apr 03, 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Ophthalmic
29d
Cleared
Jun 16, 2023
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A)...
Ophthalmic
72d
Cleared
Dec 30, 2021
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable...
Ophthalmic
52d
Cleared
Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Ophthalmic
123d
Cleared
CT
Sep 08, 2020
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Ophthalmic
127d
Cleared
Jun 08, 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58...
Ophthalmic
53d
Cleared
Jun 02, 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
Ophthalmic
150d
Cleared
May 31, 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
Ophthalmic
148d
Cleared
Jan 18, 2017
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
Ophthalmic
58d
Cleared
Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
Ophthalmic
141d