Data / Medical devices / United States / Gentex Optics, Inc.
Gentex Optics, Inc.: FDA-registered device maker in Dudley, MA, United States, 1 510(k) clearance
Gentex Optics, Inc. is registered with the FDA (registration 1215866) in Dudley, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1215866
- Address
- 183 West Main ST., Dudley, MA, United States, 01571
- Owner or operator
- Essilor of America, Inc (8010073)
- Roles
- Manufacturer
- First device listed
- December 1, 2006
- Registered through
- 2026
- Brand names listed
- Avance, Crizal, DEFINITY 2, Definity, Essilor Ideal, Essilor Stellest, Essilor Stellest Glasses, Essilor Stellest Miraflex, Kodak, Optifog and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | Manufacturer | accessdata.fda.gov |
| Prescription Spectacle Lenses To Reduce The Progression Of Myopia | QUR | 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 25, 2025 | DEN250016 | Essilor® Stellest® | QUR | Unknown | Essilor Of America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prescription Spectacle Lenses To Reduce The Progression Of Myopia
- All makers of Lens, Spectacle, Non-Custom (Prescription)
Updated September 25, 2025. 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.