Data / Medical devices / United States / Contex, Incorporated
Contex, Incorporated: FDA-registered device maker in Sherman Oaks, CA, United States, 2 510(k) clearances and 1 PMA approval
Contex, Incorporated is registered with the FDA (registration 2031102) in Sherman Oaks, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated June 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031102
- FEI number
- 2017777
- Address
- 4505 Van Nuys BLVD., Sherman Oaks, CA, United States, 91403
- Owner or operator
- Contex, Incorporated (9012202)
- Roles
- Manufacturer
- First device listed
- January 20, 2014
- Registered through
- 2026
- Brand names listed
- Contex OK Lens
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Orthokeratology) | MUW | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | 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 |
|---|---|---|---|---|---|---|
| August 28, 2000 | K001960 | RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Polymer Technology | accessdata.fda.gov |
| April 8, 1998 | K973697 | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY | MUW | Substantially Equivalent | Airperm, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 7, 2004 | P010062 | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR | NUU | 14 | December 16, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Orthokeratology)
- All makers of Lens, Contact, Orthokeratology, Overnight
- All makers of Lens, Contact (Rigid Gas Permeable), Extended Wear
- All makers of Lens, Contact (Other Material) - Daily
Updated December 16, 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.