Data / Medical devices / United States / Novavision, Inc.
Novavision, Inc.: FDA-registered device maker in Boca Raton, FL, United States, 1 510(k) clearance
Novavision, Inc. is registered with the FDA (registration 3004594297) in Boca Raton, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 22, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004594297
- Address
- 951 Broken Sound Pkwy Ste 320, Boca Raton, FL, United States, 33487
- Owner or operator
- VYCOR MEDICAL INC (9085664)
- Roles
- Manufacturer
- First device listed
- December 15, 2010
- Registered through
- 2026
- Brand names listed
- NeuroEyeCoach¿, NovaVisin VRT (Visual Restoration Therapy)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fixation, Vision Training, Binocular | NXR | 1 | Manufacturer | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | 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 |
|---|---|---|---|---|---|---|
| April 22, 2003 | K023623 | NOVAVISION, MODEL 2.0 | HPT | Substantially Equivalent | Novavision, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 22, 2003. 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.