Data / Medical devices / Canada / Innova Medical Ophthalmics
Innova Medical Ophthalmics: FDA-registered device maker in Toronto Ontario, Canada, 6 510(k) clearances
Innova Medical Ophthalmics is registered with the FDA (registration 3015972897) in Toronto Ontario, Canada. It lists 25 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 3, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015972897
- Address
- 136 Sparks Avenue, Toronto Ontario, Canada, M2H 2S4
- Owner or operator
- Innova Medical Ophthalmics (10062378)
- Roles
- Exporter to the US
- First device listed
- January 17, 2020
- Registered through
- 2026
- Brand names listed
- 2 - UP, 3M PRESS ON FRESNEL PRISM, Amoils Epithelial Scrubber, CP-2033 CHART PROJECTOR, FUNDUS/RETINAL CAMERA - COBRA, GOLF CLUB SPUD LAFORCE, Hand Held Auto Refract-Keratometer Retinomax K+Screeen, Hand Held Auto Refract-Keratometer Retinomax K-plus5 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 3, 2014 | K132987 | COBRA FUNDUS CAMERA | HKI | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| August 30, 2011 | K110129 | RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION | HJO | Substantially Equivalent | Rightmedical Products, LLC | accessdata.fda.gov |
| August 6, 2002 | K022054 | F 900 | HKY | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| June 6, 2000 | K992835 | C.S.O. TONOMETER | HKY | Substantially Equivalent | Cso | accessdata.fda.gov |
| November 9, 1999 | K992836 | SL990, SL980, SL950 | HJO | Substantially Equivalent | Cso | accessdata.fda.gov |
| January 9, 1997 | K962989 | AMOILS EPITHELIAL SCRUBBER | HOG | Substantially Equivalent | S. Percy Amoils | accessdata.fda.gov |
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Updated July 3, 2014. 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.