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510(k) K172645

iLux Instrument, iLux Disposable by Tear Film Innovations, Inc. — Product Code ORZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2017
Date Received
September 1, 2017
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.

  • K200400 — Systane iLux2 (May 21, 2020)

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  • K192623 — LipiFlow Thermal Pulsation System (October 22, 2019)
  • 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)