GEX — Powered Laser Surgical Instrument

21 CFR 878.4810

Class 2

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.

Medical Specialty

SU

Review Panel

SU

Submission Type

1

FDA Authorisations (2,854)

Device Name K-Number
Diode Laser Therapy Systems (V19) K260307
Picosecond Nd:YAG Laser Systems (Model: HS-298) K260017
Nd: YAG Laser Therapy Systems K260375
CO2 Laser System K260257
LASER THERMAL THERAPY KIT K260632
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) K252971
Picasso Pro Diode Laser (002-00460) K254197
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) K253951
CO2 Laser Treatment Machine (CFR3M1) K253920
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) K253829
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) K253828
CAPRI K254271
Diode Laser Therapy Systems (WLA-02) K252599
BTL-754FF K252561
808nm semiconductor laser hair removal machine K252048
Boston PICO (Boston PICO) K251981
Vydence Family of Lasers K252753
Holmium Laser Therapeutic Apparatus (HZ-40) K253633
Boston Pico755 K252369
PICO-K K253342
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