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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
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. 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, remove or coagulate tissue by the light.
Product CodeONE
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
DAAVLIN
  SUBSTANTIALLY EQUIVALENT 1
LED INTELLECTUAL PROPERTIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
PHAROS LIFE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SILVER BAY, LLC
  SUBSTANTIALLY EQUIVALENT 1

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