Data / Medical devices / United States / Ote' North America LLC.
Ote' North America LLC.: FDA-registered device maker in Cedarhurst, NY, United States, 2 510(k) clearances
Ote' North America LLC. is registered with the FDA (registration 3007392179) in Cedarhurst, NY, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007392179
- Address
- 381 Pearsall Ave, Cedarhurst, NY, United States, 11516
- Owner or operator
- Ote' North America LLC. (10028635)
- Roles
- Repackager or relabeler
- First device listed
- October 6, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | 2 | Repackager or relabeler | 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 26, 2021 | K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | LPN | Substantially Equivalent | Ote North America, LLC | accessdata.fda.gov |
| April 13, 2005 | K050517 | JSZ-MULTIPURPOSE SOLUTION | LPN | Substantially Equivalent | Szabocsik and Associates | accessdata.fda.gov |
Compare with other makers
Updated May 26, 2021. 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.