510(k) DEN230055 · QQJ Applicator, Negative Pressure, External, Ocular
FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System
| Applicant | Balance Ophthalmics, Inc., Sioux Falls SD, US |
| Decision | Unknown, Jun 27, 2024 |
| Received | Aug 25, 2023 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN230055
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.