DEN230055
- 510(k) number
- DEN230055
- Device name
- FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System
- Applicant
- Balance Ophthalmics, Inc. SD · US
- Product code
- QQJ — Applicator, Negative Pressure, External, Ocular
- Decision date
- 2024-06-27
- Date received
- 2023-08-25
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ophthalmic
Official FDA record: DEN230055
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.