K262479

TearCare System

510(k) number
K262479
Device name
TearCare System
Applicant
Sight Sciences, Inc. CA · US
Product code
ORZ — Eyelid Thermal Pulsation System
Decision date
2026-08-18
Date received
2026-07-20
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K262479.pdf

Official FDA record: K262479
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.