Balance Ophthalmics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027866078 | 3027866078 | Balance Ophthalmics, Inc. | 1 | N | 2026-01-01 | 3101 W 57th Street Sioux Falls SD US 57108 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319693 | 1253903844 | DEN230055 | FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System | QQJ | 2024-06-27 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QQJ | 1 | 2024-06-27 |