ART OPTICAL CONTACT LENS, INC.

FDA Device Registration & Listing · Walker, MI, US · Registration 1835957

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1835957
FEI Number
3002340631
Entity Name
ART OPTICAL CONTACT LENS, INC.
City/State/Country
Walker, MI, US
Establishment Address
3175 3 MILE RD. NW, Walker, MI 49534, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ART OPTICAL CONTACT LENS, INC. (Owner Number: 9034824)
Owner / Operator Contact Address
3175 THREE MILE RD. NW, --, Walker, MI 49534, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Optimum Extra W/THP Optimum Extreme W/THP Optimum Comfort W/THP TYRO 97 w/THP Acuity 100 w/THP Boston ES Boston ES Multivision Boston XO Boston XO2 Optimum Extra Optimum Extreme Optimum Classic Optimum Comfort Acuity 18 HEXA100 Boston XO Boston ES Boston EO Acuity 100 Optimum Infinite Boston EO Boston XO Boston ES Boston XO Boston XO2 FLOSI Boston XO w/THP Boston EO w/THP Boston ES w/THP Boston XO2 w/THP Menicon Z Acuity 200 w/THP Optimum Extra Optimum Comfort Optimum Classic Optimum Extreme Equalens II Intelliwave SA-32 SA-18 Menicon Z Intelliwave EQII Equalens

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 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2023-07-28
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
MUW Lens, Contact (Orthokeratology) Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
MUW Lens, Contact (Orthokeratology) Ophthalmic Class 2 886.5916 2019-01-31
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2019-01-31
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-10-21
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-10-21
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-14
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-08-21
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-18
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2023-05-11
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2017-09-13
MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic Class 3 886.5916 2017-09-13

Official Correspondent

Erik Anderson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ART OPTICAL CONTACT LENS, 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835957. Last updated year: 2026. Please use registration number 1835957 when referencing this establishment in official correspondence.
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