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510(k) K103266

ISTAND by Optovue, Inc. — Product Code HLI

K103266 is an FDA 510(k) premarket notification submitted by Optovue, Inc. for the device "ISTAND". The FDA issued a decision of Substantially Equivalent on June 3, 2011. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Optovue, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2011
Date Received
November 4, 2010
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

Other clearances by Optovue, Inc.

  • K222166 — SOLIX (November 9, 2022)
  • K180660 — Avanti (June 8, 2018)
  • K163475 — iVue (June 9, 2017)
  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K133892 — IVUE 500 (March 19, 2014)
  • K130656 — IFUSION (July 3, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 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)

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)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)

FDA data resources