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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light based device for dry age-related macular degeneration
Definition A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration.
Product CodeSDE
Regulation Number 886.5520
Device Class 2


Premarket Reviews
ManufacturerDecision
LUMITHERA, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 2 2
Visual Disturbances 2 2

Recalls
Manufacturer Recall Class Date Posted
1 LUMITHERA INC III Jun-30-2025
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