Data / Medical devices / Refractometer, Ophthalmic / United States
FDA-registered makers of Refractometer, Ophthalmic in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Refractometer, Ophthalmic (product code HKO). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Refractometer, Ophthalmic
- Product code
- HKO
- Country
- United States
Makers of Refractometer, Ophthalmic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 123 See | Boston, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eyeque Corporation | Newark, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gobiquity, Inc. | Nashville, TN, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heru, Inc. | Miami, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Ovitz Corporation | Rochester, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plenoptika, Inc. | Cambridge, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pursuant Health | Alpharetta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S4optik LLC | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stereo Optical Company LLC | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Healthcare, Inc. | Oakland, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.