FDA.reportPublic FDA data

ACUITY POLYMERS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30122284523012228452ACUITY POLYMERS INC.1N2026-01-011667 Lake Ave Buiding 59, Suite 303 Rochester NY US 14615

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1914671872970254P880024
1914671326252947K974636FLOSI RIGID GAS PERMEABLE CONTACT LENSHQD1998-03-30
1914671113886649K895411OPTIKEM PMMA CONTACT LENSHPX1990-02-27
1914671325341035K240618Acuity 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 LensHQD2024-04-03
1914671134870414K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensHQD2023-06-16
1914671942366770K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD2021-12-30
1914671847482285K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD2021-04-09
1914671678897054K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensHQD2020-09-08
1914671279930614K170007Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensHQD2017-05-31
1914671726769149K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensHQD2017-06-02
1914671694949619K163254Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensHQD2017-01-18
1914671369490605K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensHQD2016-12-08
1914671127711094K120756LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LELPL2013-05-13
1914671588455912K102154TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSHQD2011-01-21
1914671243197746K052507TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEARHQD2005-11-02
1914672012920513K033599ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSHQD2004-09-16
1914671811130113K000485HYDRO2, HS-75HQD2000-05-12
1914671567532645

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HQD142024-04-03
LPL12013-05-13
HPX11990-02-27