510(k) K262479
K262479 is an FDA 510(k) premarket notification submitted by Sight Sciences, Inc. for the device "TearCare System". The FDA issued a decision of Substantially Equivalent on August 18, 2026. The device falls under product code ORZ (Eyelid Thermal Pulsation System), a Class II device regulated under 21 CFR 886.5200. Sight Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2026
- Date Received
- July 20, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eyelid Thermal Pulsation System
- Device Class
- Class II
- Regulation Number
- 886.5200
- Review Panel
- OP
- Submission Type
Therapeutic application of heat and massage to the eyelids.