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U.S. Department of Health and Human Services

Radiation Emitting Electronic Product Codes

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Productpowered laser surgical instrument
Regulation DescriptionLaser surgical instrument for use in general and plastic surgery and in dermatology.
Definition A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, 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. 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 Description General & Plastic Surgery Medical Laser Products
Product CodeGEX
Radiation Type Optical
Radiation Safety Report Type Required? Product
Annual Reports Required? Yes
Regulation Number 878.4810
Applicable Performance Standard(s) Laser products. [1040.10]
Specific purpose laser products. [1040.11]

Guidance Document

  • Guidance on the Content and Organization of a Premarket Notification for a Medical Laser