510(k) clearance

TearCare System

FDA 510(k) source

510(k) number

K262479

Applicant

Sight Sciences, Inc.

Decision date

Aug 18, 2026

Date received

Jul 20, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

ORZ

Device type

Eyelid Thermal Pulsation System

Device class

Class II

Regulation

21 CFR 886.5200

Advisory committee

Ophthalmic

Statement or summary

Summary

Third party

N

Location

Menlo Park, CA, US