TearCare System— 510(k) K262479
Substantially EquivalentSight Sciences, Inc.
FDA 510(k) clearance K262479 for TearCare System, Substantially Equivalent on 2026-08-18. Applicant: Sight Sciences, Inc.. Device class: 2.
Summary
Sight Sciences' TearCare System is filed under product code ORZ, eyelid thermal pulsation systems. The record gives no model numbers or further description.
Class II, 21 CFR 886.5200. Ophthalmic is both the classification panel and the review panel, and it came in as a Special 510(k).
Sight Sciences filed from Menlo Park, California. The decision came 29 calendar days after FDA received it (July 20 to August 18, 2026), and it was substantially equivalent.
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
- Special
- Location
- Menlo Park, CA, US
Recent devices under product code ORZ
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