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510(k) K182506

LipiScan Dynamic Meibomian Imager by Tearscience, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2018
Date Received
September 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Tearscience, Inc.

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

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