Data / Medical devices / United States / Art Optical Contact Lens, Inc.
Art Optical Contact Lens, Inc.: FDA-registered device maker in Walker, MI, United States, 3 510(k) clearances
Art Optical Contact Lens, Inc. is registered with the FDA (registration 1835957) in Walker, MI, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 14, 2010. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1835957
- FEI number
- 3002340631
- Address
- 3175 3 Mile RD. NW, Walker, MI, United States, 49534
- Owner or operator
- ART OPTICAL CONTACT LENS, INC. (9034824)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 21, 2008
- Registered through
- 2027
- Brand names listed
- Acuity 100, Acuity 100 w/THP, Acuity 18, Acuity 200, Acuity 200 w/THP, Acuity 58, Boston EO, Boston EO w/THP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Orthokeratology) | MUW | 2 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Polymethylmethacrylate) | HPX | U | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Contract manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 14, 2010 | K100221 | INTELLIWAVE3 | LPL | Substantially Equivalent | Art Optical Contact Lens, Inc. | accessdata.fda.gov |
| July 3, 2008 | K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | LPL | Substantially Equivalent | Art Optical Contact Lens, Inc. | accessdata.fda.gov |
| March 7, 1997 | K964528 | (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT | LPL | Substantially Equivalent | Benz Research and Development Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lens, Contact (Orthokeratology)
- All makers of Lens, Contact (Rigid Gas Permeable), Extended Wear
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact (Polymethylmethacrylate)
Updated September 14, 2010. 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.