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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ophthalmoscope, laser, scanning
Product CodeMYC
Regulation Number 886.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERVUE SPA
  SUBSTANTIALLY EQUIVALENT 8
FREEDOM MEDITECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
I-OPTICS BV
  SUBSTANTIALLY EQUIVALENT 1
KOWA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPTOS PLC
  SUBSTANTIALLY EQUIVALENT 4
OPTOS PLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Convulsion/Seizure 3 3

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