Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
- CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. - CO2 LASER PART YOULASER CO2 laser when used in traditional, non-fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing. - HF electrosurgical Part: The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
- CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. -HF electrosurgical Part: The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The FRAXIS DUO is a surgical instrument that combines CO2 laser and high-frequency electrosurgical capabilities. The CO2 laser part features a fractional mode for ablative skin resurfacing and a non-fractional mode for various surgical applications. The device includes an articulated arm with a scanner and normal handpieces for laser delivery, and a bipolar handpiece for the electrosurgical part. It operates with a color touch panel interface and has specific electrical requirements.
Summary parsed at:2026-06-01 06:05:48 UTC
