510(k) Report

FDA applicant

Acuity Polymers, Inc.

Rochester, NY11 decisions2016–20240 recalls

FDA records 11 decisions for Acuity Polymers, Inc. (Rochester, NY) from 2016 to 2024: 11 510(k) clearances. All are in product code HQD (Lens, Contact (Other Material) - Daily). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Acuity Polymers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2016: 12017: 32018: 12020: 12021: 22023: 12024: 2
2016high 3 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Acuity Polymers, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQDLens, Contact (Other Material) - Daily11decisions

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 79 days; 4 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 27 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 20204cite it
  • K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 20163cite it
  • K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas…Acuity Polymers, Inc. · 20243cite it
  • K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 20213cite it
  • K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 20171cites it
  • K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 20211cites it

What has FDA decided for it lately?

  • K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable…Acuity Polymers, Inc. · 2024
  • K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas…Acuity Polymers, Inc. · 2024
  • K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid…Acuity Polymers, Inc. · 2023
  • K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
  • K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
  • K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2020
  • K180988Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable…Acuity Polymers, Inc. · 2018
  • K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2017

All 11 as Acuity Polymers, Inc. →

Other applicant names beginning “Acuity”

FDA records each applicant name separately; these may or may not be the same firm.

Acuity Surgical Devices, LLC 8