Data / Medical devices / United States / OCuSOFT LLC
OCuSOFT LLC: FDA-registered device maker in Rosenberg, TX, United States, 2 510(k) clearances
OCuSOFT LLC is registered with the FDA (registration 1641445) in Rosenberg, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 24, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1641445
- Address
- 30444 Southwest Fwy bldg. B, Rosenberg, TX, United States, 77471
- Owner or operator
- OCuSOFT LLC (10094687)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 16, 2025
- Registered through
- 2026
- Brand names listed
- OPAQUE HERRICK LACRIMAL PLUG, Tear Pool Dissolvable Punctum Plugs, Thermal 1-Touch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Heating, Powered | IRT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| October 24, 2019 | K190210 | Tear Pool Dissolvable Punctum Plugs | LZU | Substantially Equivalent | Alphamed, Inc. | accessdata.fda.gov |
| May 9, 2003 | K030300 | OPAQUE HERRICK LACRIMAL PLUG | LZU | Substantially Equivalent | Lacrimedics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2019. 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.