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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device contact cooling for skin lesion pain relief
Regulation Description Contact cooling system for aesthetic use.
Definition For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
Product CodeQPZ
Regulation Number 878.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
R2 TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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