Data / Medical devices / United States / Acuity Polymers Inc.
Acuity Polymers Inc.: FDA-registered device maker in Rochester, NY, United States, 16 510(k) clearances and 1 PMA approval
Acuity Polymers Inc. is registered with the FDA (registration 3012228452) in Rochester, NY, United States. It lists 3 device types. The FDA files 16 510(k) clearances and 1 PMA approval under its listings, the newest dated April 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012228452
- Address
- 1667 Lake Ave Buiding 59, Suite 303, Rochester, NY, United States, 14615
- Owner or operator
- Acuity Polymers, Inc. (10051193)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 11, 2017
- Registered through
- 2026
- Brand names listed
- Acuity 100 (hexafocon A), Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG®, Acuity 18 (enflufocon A), Acuity 200, Acuity 200 (fluoroxyfocon A) Irregular Cornea indications, Acuity 200 (fluoroxyfocon A) and Acuity 100 (hexafocon A) GP Contact Lens; with and without Tangible Hydra-PEG, Acuity 200 Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lens, Contact (Polymethylmethacrylate) | HPX | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 3, 2024 | 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 Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| June 16, 2023 | K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| December 30, 2021 | K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| April 9, 2021 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| September 8, 2020 | K201194 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| June 2, 2017 | K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| May 31, 2017 | K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| January 18, 2017 | K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| December 8, 2016 | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| May 13, 2013 | K120756 | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE | LPL | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| January 21, 2011 | K102154 | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| November 2, 2005 | K052507 | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR | HQD | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| September 16, 2004 | K033599 | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| May 12, 2000 | K000485 | HYDRO2, HS-75 | HQD | Substantially Equivalent | Innovision, Inc. | accessdata.fda.gov |
| March 30, 1998 | K974636 | FLOSI RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Futuristic Design Assoc. | accessdata.fda.gov |
| February 27, 1990 | K895411 | OPTIKEM PMMA CONTACT LENS | HPX | Substantially Equivalent | Optikem Polymers, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 24, 1994 | P880024 | N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL | HQD | 2 | March 4, 1994 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact (Polymethylmethacrylate)
Updated April 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.