Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012228452

FEI Number

3012228452

Entity Name

ACUITY POLYMERS INC.

City/State/Country

Rochester, NY, US

Establishment Address

1667 Lake Ave, Buiding 59, Suite 303, Rochester, NY 14615, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Acuity Polymers, Inc. (Owner Number: 10051193)

Owner / Operator Contact Address

1667 Lake Avenue, Building 59, Suite 303, Rochester, NY 14615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102154

PMA Number

N/A

All Registered Proprietary Names

Onsi-56 Acuity 200 Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity 200 (fluoroxyfocon A) Irregular Cornea indications Lagado LSH Acuity 58 (enflufocon B) Acuity 18 (enflufocon A) Acuity 100 (hexafocon A) Tyro-97 Acuity 85 (oprifocon A) PMMA Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Acuity 200 (fluoroxyfocon A) and Acuity 100 (hexafocon A) GP Contact Lens; with and without Tangible Hydra-PEG Acuity 200 TYRO-97 (hofocon A) and ONSI 56 (onsifocon A) Irregular Cornea indications

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2019-01-07
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-08-15
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-08-15
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-01-07
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2017-09-27
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2017-09-27
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2017-01-11
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2019-01-07
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2017-09-27
HPX	Lens, Contact (Polymethylmethacrylate)	Unknown	Class U	N/A	2019-01-07
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-06-19
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2024-05-01
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2020-10-20
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Acuity Polymers, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963512	Benz Research and Development Corp.	BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL	1997-07-31
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Similar Registrations

Registration Number	Establishment Name	Location
3032010300	TIANJIN MASTERVISION TECHNOLOGY CO., LTD.	Wuqing District Tianjin, CN
3005994941	SOLOTICA INDUSTRIA E COMERCIO LTDA	Sao Paulo, BR
3010607087	Menicon Nect Co., Ltd., Gujo Plant	Gujo Gifu, JP
1835957	ART OPTICAL CONTACT LENS, INC.	Walker, MI, US
3025308027	BIOLENS LAB	Mohammedia Mohammadia, MA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012228452. Last updated year: 2026. Please use registration number 3012228452 when referencing this establishment in official correspondence.