Medical Device Manufacturer · US , Rochester , NY

Acuity Polymers, Inc.

11 submissions · 11 cleared · Since 2016
11
Total
11
Cleared
0
Denied

Acuity Polymers, Inc. — FDA 510(k) Submissions

Acuity Polymers, Inc. has submitted 11 FDA 510(k) premarket notifications since 2016, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lens, Contact (other Material) - Daily . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Acuity 181? (tisilfocon A) and Acuity 181? (tisilfocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lenses
K242393 · HQD Lens, Contact (other... · Ophthalmic
Nov 2024 80d
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 Lens
K240618 · HQD Lens, Contact (other... · Ophthalmic
Apr 2024 29d
Acuity 100? (hexafocon A) with Tangible? Hydra-PEG?, TYRO?-97 (hofocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lens
K230965 · HQD Lens, Contact (other... · Ophthalmic
Jun 2023 72d
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K213538 · HQD Lens, Contact (other... · Ophthalmic
Dec 2021 52d
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K203571 · HQD Lens, Contact (other... · Ophthalmic
Apr 2021 123d
Acuity 200? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194 · HQD Lens, Contact (other... · Ophthalmic
Sep 2020 127d
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 Lens
K180988 · HQD Lens, Contact (other... · Ophthalmic
Jun 2018 53d
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
K170001 · HQD Lens, Contact (other... · Ophthalmic
Jun 2017 150d
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
K170007 · HQD Lens, Contact (other... · Ophthalmic
May 2017 148d
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
K163254 · HQD Lens, Contact (other... · Ophthalmic
Jan 2017 58d
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K162005 · HQD Lens, Contact (other... · Ophthalmic
Dec 2016 141d
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