K252409
- 510(k) number
- K252409
- Device name
- TearCare MGX System
- Applicant
- Sight Sciences, Inc. CA · US
- Product code
- ORZ — Eyelid Thermal Pulsation System
- Decision date
- 2026-04-27
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252409.pdf
Official FDA record: K252409
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.