K253760
- 510(k) number
- K253760
- Device name
- OMNI Ultra Surgical System (1-110)
- Applicant
- Sight Sciences, Inc. CA · US
- Product code
- MRH — Pump, Infusion, Ophthalmic
- Decision date
- 2026-08-04
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253760.pdf
Official FDA record: K253760
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.