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510(k) K121739

IVUE WITH NORMATIVE DATABASE by Optovue, Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2013
Date Received
June 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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  • K130656 — IFUSION (July 3, 2013)
  • K122572 — ICAM FUNDUS CAMERA (January 11, 2013)
  • K120238 — RTVUE XR OCT (April 3, 2012)
  • K111505 — RTVUE CAM WITH CORNEAL POWER UPGRADE (September 8, 2011)
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Other clearances for product code HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K150722 — EnFocus 2300, EnFocus 4400 (December 2, 2015)
  • K142953 — OCT-Camera (March 4, 2015)
  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (September 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (March 26, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)
  • K120238 — RTVUE XR OCT (April 3, 2012)