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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
Regulation Description Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
Product CodeLXS
Regulation Number 886.4392
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 1
Total Device Problems 1

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