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510(k) K133758

CENTERVUE MACULAR INTEGRITY ASSESSMENT by Centervue S.P.A. — Product Code HLI

K133758 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "CENTERVUE MACULAR INTEGRITY ASSESSMENT". The FDA issued a decision of Substantially Equivalent on April 23, 2014. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Centervue S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2014
Date Received
December 11, 2013
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 Centervue S.P.A.

  • K243504 — MAIA (AHMACME001) (March 17, 2025)
  • K234076 — iCare ALTIUS CW (August 22, 2024)
  • K213705 — DRSplus (December 21, 2021)
  • K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL (August 19, 2021)
  • K192113 — DRSplus (November 15, 2019)
  • K180526 — EIDON FA (July 16, 2018)
  • K180293 — Retia 2 (May 30, 2018)
  • K153181 — MAIA (June 8, 2016)
  • K150320 — COMPASS (June 30, 2015)
  • K142047 — EIDON (November 12, 2014)

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)
  • 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)
  • K120238 — RTVUE XR OCT (April 3, 2012)

FDA data resources