Data / Medical devices / United States / Dry Eye Innovations, LLC
Dry Eye Innovations, LLC: FDA-registered device maker in Franklin, TN, United States, 2 510(k) clearances
Dry Eye Innovations, LLC is registered with the FDA (registration 3016440358) in Franklin, TN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 31, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016440358
- Address
- 5051 Kathryn Ave, Franklin, TN, United States, 37064
- Owner or operator
- Dry Eye Innovations, LLC (10062370)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 17, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 31, 2020 | K201069 | VibrantVue Scleral Saline | MRC | Substantially Equivalent | Dry Eye Innovations, LLC | accessdata.fda.gov |
| December 11, 2012 | K113693 | NIXALL TM WOUND AND SKIN CARE | FRO | Substantially Equivalent | Seriously Clean, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 31, 2020. 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.