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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intense pulsed light device for managing dry eye
Definition An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
Product CodeQIU
Regulation Number 886.5201
Device Class 2


Premarket Reviews
ManufacturerDecision
LUMENIS LTD.
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 1 1

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