Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
When used in traditional, non-fractionated mode 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), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
When used in traditional, non-fractionated mode 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), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
YOULASER CO2 laser device has a CO2 laser source emitting at 10600 nm. The beam delivery is enabled through an articulated arm. Emission is triggered by means of the footswitch or the finger switch available on the scanner. An embedded PC is added to manage the GUI. A proprietary Scanner – Optiscan – is introduced. Emission is triggered also from a fingerswitch mounted on the scanner. Change to the GUI appearance. Change to the external panels.
Summary parsed at:2026-06-01 05:58:03 UTC
