Data / Medical devices / United States / Balance Ophthalmics, Inc.
Balance Ophthalmics, Inc.: FDA-registered device maker in Sioux Falls, SD, United States, 2 510(k) clearances
Balance Ophthalmics, Inc. is registered with the FDA (registration 3027866078) in Sioux Falls, SD, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027866078
- Address
- 3101 W 57th Street, Sioux Falls, SD, United States, 57108
- Owner or operator
- Balance Ophthalmics, Inc. (10088563)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 22, 2024
- Registered through
- 2027
- Brand names listed
- FSYX Ocular Pressure Adjusting Pump, FSYX(TM) Ocular Pressure Adjusting Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Negative Pressure, External, Ocular | QQJ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 30, 2026 | K252455 | FSYX Ocular Pressure Adjusting Pump | QQJ | Substantially Equivalent | Balance Ophthalmics, Inc. | accessdata.fda.gov |
| June 27, 2024 | DEN230055 | FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System | QQJ | Unknown | Balance Ophthalmics, Inc. | accessdata.fda.gov |
Updated April 30, 2026. 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.