Medical Device Manufacturer · US , Sioux Falls , SD

Balance Ophthalmics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2024
Official Website
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Balance Ophthalmics, Inc. Ophthalmic ✕
2 devices
1-2 of 2
Cleared Apr 30, 2026
FSYX Ocular Pressure Adjusting Pump
K252455 · QQJ
Ophthalmic · 268d
Not Cleared Jun 27, 2024
FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
DEN230055 · QQJ
Ophthalmic · 307d
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