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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, assisted reproduction laser
Regulation Description Assisted reproduction laser system.
Definition This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.
Product CodeMRX
Regulation Number 884.6200
Device Class 2


Premarket Reviews
ManufacturerDecision
HAMILTON THORNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUA YUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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