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510(k) K200400

Systane iLux2 by Tear Film Innovations, Inc. — Product Code ORZ

K200400 is an FDA 510(k) premarket notification submitted by Tear Film Innovations, Inc. for the device "Systane iLux2". The FDA issued a decision of Substantially Equivalent on May 21, 2020. The device falls under product code ORZ (Eyelid Thermal Pulsation System), a Class II device regulated under 21 CFR 886.5200. Tear Film Innovations, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2020
Date Received
February 18, 2020
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 Tear Film Innovations, Inc.

  • K172645 — iLux Instrument, iLux Disposable (December 26, 2017)

Other clearances for product code ORZ

  • K262479 — TearCare System (August 18, 2026)
  • 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)
  • 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)

FDA data resources