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510(k) K211328

EIDON FA, EIDON, EIDON AF, EIDON UWFL by Centervue S.P.A. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2021
Date Received
May 3, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
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)
  • 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)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)

Other clearances for product code MYC

  • K241931 — OcuMet Beacon (OCUB100) (April 22, 2025)
  • K243504 — MAIA (AHMACME001) (March 17, 2025)
  • K213705 — DRSplus (December 21, 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)
  • K142897 — P200DTx (January 16, 2015)
  • K142047 — EIDON (November 12, 2014)