Data / Medical devices / United States / Nova Eye Inc.
Nova Eye Inc.: FDA-registered device maker in Fremont, CA, United States, 4 510(k) clearances
Nova Eye Inc. is registered with the FDA (registration 3005641545) in Fremont, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 30, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005641545
- Address
- 41316 Christy St, Fremont, CA, United States, 94538
- Owner or operator
- Nova Eye Medical Ltd (10075633)
- Roles
- Manufacturer
- First device listed
- June 22, 2020
- Registered through
- 2026
- Brand names listed
- Canaloplasty Microcather, Viscoinjector, iLumin, iTrack 250A, iTrack Advance
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Endoilluminator | MPA | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Ophthalmic | MRH | 2 | 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 |
|---|---|---|---|---|---|---|
| March 30, 2023 | K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | MPA | Substantially Equivalent | Nova Eye Inc. (Business Name Nova Eye Medical) | accessdata.fda.gov |
| July 18, 2008 | K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER | MPA | Substantially Equivalent | Iscience Interventional | accessdata.fda.gov |
| August 15, 2006 | K062259 | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 | MPA | Substantially Equivalent | Iscience Surgical | accessdata.fda.gov |
| April 21, 2005 | K050716 | ISCIENCE SURGICAL VISCOINJECTOR | MRH | Substantially Equivalent | Iscience Surgical Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 11, 2018 | 80569 | Class II | Terminated | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. | Sterility failure found in one of the units in the lot. | accessdata.fda.gov |
| August 6, 2014 | 69021 | Class II | Terminated | iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery. | One lot may not have been properly sealed, resulting in a non-sterile device. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion, Ophthalmic
- All makers of Endoilluminator
- All makers of Cannula, Ophthalmic
Updated March 30, 2023. 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.