K231084
- 510(k) number
- K231084
- Device name
- TearCare MGX System
- Applicant
- Sight Sciences, Inc. CA · US
- Product code
- ORZ — Eyelid Thermal Pulsation System
- Decision date
- 2023-12-27
- Date received
- 2023-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
510(k) Summary (official FDA PDF): K231084.pdf
Official FDA record: K231084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.