510(k) K252455 ยท QQJ Applicator, Negative Pressure, External, Ocular
FSYX Ocular Pressure Adjusting Pump
| Applicant | Balance Ophthalmics, Inc., Sioux Falls SD, US |
| Decision | Substantially Equivalent, Apr 30, 2026 |
| Received | Aug 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252455
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.