TearCare MGX System
by Sight Sciences, Inc. 3 variants
510(k) K252409
TearCare MGX System is a Class II device made by Sight Sciences, Inc., cleared under FDA 510(k) K252409 on 27 Apr 2026, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252409 | Date27 Apr 2026 | StatusActive |
Official records
- FDA 510(k) database K252409
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ORZ
- Device class
- Class II
- Regulation
- 21 CFR Part 886.5200
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent