Product code GEX

Device name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4810
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset