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510(k) K122481

LIPIVIEW OCULAR SURFACE INTERFEROMETER by Tearscience, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2012
Date Received
August 14, 2012
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.

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  • 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)
  • 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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