TearCare MGX System— 510(k) K252409
Substantially EquivalentSight Sciences, Inc.
FDA 510(k) clearance K252409 for TearCare MGX System, Substantially Equivalent on 2026-04-27. Applicant: Sight Sciences, Inc.. Device class: 2.
Summary
Sight Sciences' TearCare MGX System is filed under product code ORZ (Eyelid Thermal Pulsation System).
Class II, 21 CFR 886.5200. It came in as a Traditional 510(k), and Ophthalmic is both the classification panel and the review panel.
Sight Sciences filed from Menlo Park, California. Review took 269 calendar days (August 1, 2025 to April 27, 2026).
Clearance details
- Applicant
- Sight Sciences, Inc.
- Product code
- Product code ORZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.5200
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code ORZ
view allMore clearances from Sight Sciences, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.