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K242786

TearCare MGX System

510(k) number
K242786
Device name
TearCare MGX System
Applicant
Sight Sciences, Inc. CA · US
Product code
ORZ — Eyelid Thermal Pulsation System
Decision date
2025-04-15
Date received
2024-09-16
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K242786.pdf

Official FDA record: K242786
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.