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510(k) K152869

LipiView II Ocular Surface Interferometer by Tearscience, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2016
Date Received
September 30, 2015
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)
  • K182506 — LipiScan Dynamic Meibomian Imager (December 10, 2018)
  • K161357 — LipiFlow Thermal Pulsation System (November 4, 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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