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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital therapy device for amblyopia
Definition A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.
Product CodeQQU
Regulation Number 886.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
LUMINOPIA, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3
NOVASIGHT , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Vomiting 1 1
Eye Pain 1 1

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