Data / Medical devices / United States / Konan Medical Usa, Inc.
Konan Medical Usa, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Konan Medical Usa, Inc. is registered with the FDA (registration 3005955744) in Irvine, CA, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 15, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005955744
- Address
- 15770 Laguna Canyon Road Suite 150, Irvine, CA, United States, 92618
- Owner or operator
- KONAN MEDICAL USA, INC. (10027489)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 7, 2011
- Registered through
- 2026
- Brand names listed
- CHINREST, COLORDx CCT HD, EVOKEDx, EYEKINETIX, M339 DME CARBON CL, M379 DME CARBON R, objectiveFIELD Analyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pupillograph | HRI | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Instrument, Ophthalmic, Non-Powered | HMG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Manufacturer | accessdata.fda.gov |
| Tester, Color Vision | HIT | 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 |
|---|---|---|---|---|---|---|
| May 15, 2009 | K081591 | NEUCODIA | GWE | Substantially Equivalent | Verisci Corporation | accessdata.fda.gov |
| August 2, 2007 | K063310 | TRUEFIELD ANALYZER | HPT | Substantially Equivalent | Seeing Machines Limited | accessdata.fda.gov |
| July 5, 2000 | K001117 | COMFORT STIM | GXY | Substantially Equivalent | R & D Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stand, Instrument, Ophthalmic, Non-Powered
- All makers of Perimeter, Automatic, Ac-Powered
- All makers of Pupillograph
- All makers of Tester, Color Vision
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Photic, Evoked Response
Updated May 15, 2009. 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.