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510(k) K162039

OptosAdvance 4.0 Software by Optos Plc. — Product Code NFJ

K162039 is an FDA 510(k) premarket notification submitted by Optos Plc. for the device "OptosAdvance 4.0 Software". The FDA issued a decision of Substantially Equivalent on February 8, 2017. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Optos Plc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2017
Date Received
July 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

Other clearances by Optos Plc.

  • K233602 — P200TE (A10700) (May 9, 2024)
  • K231673 — P200TE (A10700) (August 18, 2023)
  • K190732 — P200TxE (July 31, 2019)
  • K173707 — P200TE (February 28, 2018)
  • K142897 — P200DTx (January 16, 2015)
  • K134039 — DAYTONA ICG (P200TICG) (April 11, 2014)
  • K121043 — OPTOS OCT/SLO MICROPERIMETER (February 22, 2013)
  • K113696 — OPTOS ADVANCE (May 25, 2012)
  • K111628 — P200T (August 19, 2011)
  • K102492 — P200MAAF (September 30, 2010)

Other clearances for product code NFJ

  • K260694 — ZEISS CLINIC 360 (July 17, 2026)
  • K253893 — Harmony Referral System with Harmony OCT Viewer (Octave) (June 4, 2026)
  • K234076 — iCare ALTIUS CW (August 22, 2024)
  • K232828 — IMAGEnet6 Ophthalmic Data System (March 1, 2024)
  • K232944 — CALLISTO eye (December 21, 2023)
  • K232555 — Harmony (November 20, 2023)
  • K231676 — CALLISTO eye (August 28, 2023)
  • K232088 — Altris IMS (July 31, 2023)
  • K220929 — Excelsior (October 31, 2022)
  • K213527 — FORUM (August 15, 2022)

FDA data resources