FDA applicant
Balance Ophthalmics, Inc.
FDA records 2 decisions for Balance Ophthalmics, Inc. (Sioux Falls, SD) from 2024 to 2026: 1 510(k) clearance and 1 De Novo grant. All are in product code QQJ (Applicator, Negative Pressure, External, Ocular). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Balance Ophthalmics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Balance Ophthalmics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report