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510(k) K142897

P200DTx by Optos Plc. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2015
Date Received
October 3, 2014
Clearance Type
Traditional
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 Optos Plc.

  • K233602 — P200TE (A10700) (May 9, 2024)
  • K231673 — P200TE (A10700) (August 18, 2023)
  • K190732 — P200TxE (July 31, 2019)
  • K173707 — P200TE (February 28, 2018)
  • K162039 — OptosAdvance 4.0 Software (February 8, 2017)
  • 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 MYC

  • K241931 — OcuMet Beacon (OCUB100) (April 22, 2025)
  • K243504 — MAIA (AHMACME001) (March 17, 2025)
  • 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)