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The Tracker / August 2026 / K262479

510(k) cleared

TearCare System

Sight Sciences, Inc. · Aug 18, 2026 · K262479

FDA cleared the TearCare System from Sight Sciences, Inc. on Aug 18, 2026 under K262479, a special 510(k). The device falls under product code ORZ, Eyelid Thermal Pulsation System, regulated at 21 CFR 886.5200 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jul 20, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Sight Sciences, Inc. has 2 other decisions in the tracker over the last 12 months: K253760 (OMNI Ultra Surgical System (1-110)), K252409 (TearCare MGX System).

Questions & Answers

What did FDA clear under K262479?

K262479 is the FDA 510(k) for TearCare System, submitted by Sight Sciences, Inc.. FDA's decision date was Aug 18, 2026, under product code ORZ (Eyelid Thermal Pulsation System).

Who makes the TearCare System?

Sight Sciences, Inc., based in Menlo Park, CA, is the applicant of record for K262479.

How long did the K262479 review take?

FDA received the submission on Jul 20, 2026 and issued its decision on Aug 18, 2026, 29 days later.

← All decisions in August 2026

Sources