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TearCare System

by Sight Sciences, Inc. 2 variants

510(k) K262479

TearCare System is a Class II device made by Sight Sciences, Inc., cleared under FDA 510(k) K262479 on 18 Aug 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK262479 Date18 Aug 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ORZ
Device class
Class II
Regulation
21 CFR Part 886.5200
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

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