K252455
- 510(k) number
- K252455
- Device name
- FSYX Ocular Pressure Adjusting Pump
- Applicant
- Balance Ophthalmics, Inc. SD · US
- Product code
- QQJ — Applicator, Negative Pressure, External, Ocular
- Decision date
- 2026-04-30
- Date received
- 2025-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252455.pdf
Official FDA record: K252455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.