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510(k) K192623

LipiFlow Thermal Pulsation System by Tearscience, Inc. — Product Code ORZ

K192623 is an FDA 510(k) premarket notification submitted by Tearscience, Inc. for the device "LipiFlow Thermal Pulsation System". The FDA issued a decision of Substantially Equivalent on October 22, 2019. The device falls under product code ORZ (Eyelid Thermal Pulsation System), a Class II device regulated under 21 CFR 886.5200. Tearscience, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2019
Date Received
September 23, 2019
Clearance Type
Special
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 Tearscience, Inc.

  • K182506 — LipiScan Dynamic Meibomian Imager (December 10, 2018)
  • K161357 — LipiFlow Thermal Pulsation System (November 4, 2016)
  • K152869 — LipiView II Ocular Surface Interferometer (January 14, 2016)
  • K133127 — LIPIFLOW THERMAL PULSATION SYSTEM (December 23, 2013)
  • K122481 — LIPIVIEW OCULAR SURFACE INTERFEROMETER (December 31, 2012)
  • K112704 — LIPIFLOW THERMAL PULSATION SYSTEM (December 19, 2011)
  • DEN100017 — LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (June 28, 2011)
  • K091935 — LIPIVIEW OCULAR SURFACE INTERFEROMETER (October 23, 2009)

Other clearances for product code ORZ

  • K252409 — TearCare MGX System (April 27, 2026)
  • K242786 — TearCare MGX System (April 15, 2025)
  • 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)
  • 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)

FDA data resources