Powered Laser Surgical Instrument 510(k) Clearances

Product code GEX is the FDA classification for Powered Laser Surgical Instrument, a Class 2 device regulated under 21 CFR 878.4810, reviewed by the FDA General, Plastic Surgery panel. FDA has cleared 2,866 510(k) submissions under this product code.

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.

Every device cleared under product code GEX shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.