Data / Medical devices / Lens, Contact (Orthokeratology)
Lens, Contact (Orthokeratology) (MUW): 16 FDA-registered makers in 4 countries
16 establishments in 4 countries are registered with the FDA to make Lens, Contact (Orthokeratology) (product code MUW, Class 2, 21 CFR 886.5916). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on January 9, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MUW
- Device class
- 2
- Regulation
- 886.5916
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Canada | 2 |
| United Kingdom | 1 |
| Morocco | 1 |
Makers of Lens, Contact (Orthokeratology)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Contamac Ltd. | Essex Uk, United Kingdom | Manufacturer | 1 | July 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Contex, Incorporated | Sherman Oaks, CA, United States | Manufacturer | 1 | April 8, 1998 | 0 | 0 | 0 | api.fda.gov |
| Acculens, Inc. | Golden, CO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Vision Technologies | Lakewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Art Optical Contact Lens, Inc. | Walker, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurora GP Lab Inc | Goodyear, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolens Lab | Mohammedia Mohammadia, Morocco | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blanchard Vision Corp. | SHERBROOKE Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Wilmington, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cler Vision Inc. | Riverside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hedgefog Research Inc. | San Pedro, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optik K & R Inc. | Toronto Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visionary Contact Lens, Inc. | Anaheim, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visionary Optics, LLC | Front Royal, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visionary Optics, LLC | Sterling, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-Cel Specialty Contacts | Duluth, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 2019. 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.