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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered light based non-laser surgical instrument with thermal effect
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.
Product CodeONF
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
Ellipse A/S
  SUBSTANTIALLY EQUIVALENT 1
GENESIS BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNERON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 2
Improper or incorrect procedure or method 2
No Known Device Problem 1
Accessory incompatible 1
Total Device Problems 6

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