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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser for gastro-urology use
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Product CodeLNK
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Burn of device or device component 1
Disconnection 1
Total Device Problems 2

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