Acuity 181? (tisilfocon A) and Acuity 181? (tisilfocon A) with Tangible? Hydra-PEG® Rigid Gas Permeable Contact Lenses
Acuity Polymers, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012228452 | 3012228452 | ACUITY POLYMERS INC. | 1 | N | 2026-01-01 | 1667 Lake Ave Buiding 59, Suite 303 Rochester NY US 14615 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850203008002 | Acuity - Rigid-gas-permeable contact lens - daily wear hexafocon A | 585-458-8094 | danielle.savino@acuitypolymers.com |
| 00850203008002 | Acuity - Rigid-gas-permeable contact lens - daily wear hexafocon A | 585-458-8094 | lisa.sidebotham@acuitypolymers.com |
| 00850203008019 | Acuity - Rigid-gas-permeable contact lens - daily wear enflufocon A | 585-458-8094 | danielle.savino@acuitypolymers.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 191467 | 1872970254 | P880024 | |||
| 191467 | 1326252947 | K974636 | FLOSI RIGID GAS PERMEABLE CONTACT LENS | HQD | 1998-03-30 |
| 191467 | 1113886649 | K895411 | OPTIKEM PMMA CONTACT LENS | HPX | 1990-02-27 |
| 191467 | 1325341035 | 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 | 2024-04-03 |
| 191467 | 1134870414 | K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens | HQD | 2023-06-16 |
| 191467 | 1942366770 | K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | 2021-12-30 |
| 191467 | 1847482285 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | 2021-04-09 |
| 191467 | 1678897054 | K201194 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | 2020-09-08 |
| 191467 | 1279930614 | K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | HQD | 2017-05-31 |
| 191467 | 1726769149 | K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens | HQD | 2017-06-02 |
| 191467 | 1694949619 | K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | HQD | 2017-01-18 |
| 191467 | 1369490605 | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | 2016-12-08 |
| 191467 | 1127711094 | K120756 | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE | LPL | 2013-05-13 |
| 191467 | 1588455912 | K102154 | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | 2011-01-21 |
| 191467 | 1243197746 | K052507 | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR | HQD | 2005-11-02 |
| 191467 | 2012920513 | K033599 | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | 2004-09-16 |
| 191467 | 1811130113 | K000485 | HYDRO2, HS-75 | HQD | 2000-05-12 |
| 191467 | 1567532645 |
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
Acuity Polymers, Inc.
2025-06-09
2025-06-09
2017-09-27
2017-09-28
2017-09-28
2017-09-28