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510(k) K242786

TearCare MGX System by Sight Sciences, Inc. — Product Code ORZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2025
Date Received
September 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eyelid Thermal Pulsation System
Device Class
Class II
Regulation Number
886.5200
Review Panel
OP
Submission Type

Therapeutic application of heat and massage to the eyelids.

Other clearances by Sight Sciences, Inc.

  • K231084 — TearCare MGX System (December 27, 2023)
  • K232214 — OMNI Surgical System (August 25, 2023)
  • K213045 — TearCare System (December 21, 2021)
  • K202678 — OMNI Surgical System (March 1, 2021)
  • K201953 — OMNI PLUS Surgical System (August 11, 2020)
  • K173332 — OMNI Surgical System (December 21, 2017)
  • K171905 — VISCO 360 Viscosurgical System (July 27, 2017)
  • K143205 — Viscoelastic Injector (December 5, 2014)
  • K132494 — VISCOELASTIC INJECTOR (October 22, 2013)

Other clearances for product code ORZ

  • K240512 — Tixel i (TXLI0001) (November 4, 2024)
  • K231084 — TearCare MGX System (December 27, 2023)
  • K213045 — TearCare System (December 21, 2021)
  • K200400 — Systane iLux2 (May 21, 2020)
  • K192623 — LipiFlow Thermal Pulsation System (October 22, 2019)
  • K172645 — iLux Instrument, iLux Disposable (December 26, 2017)
  • K161357 — LipiFlow Thermal Pulsation System (November 4, 2016)
  • K133127 — LIPIFLOW THERMAL PULSATION SYSTEM (December 23, 2013)
  • K112704 — LIPIFLOW THERMAL PULSATION SYSTEM (December 19, 2011)
  • DEN100017 — LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (June 28, 2011)