El.En Electronic Engineering Spa
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.
Summary parsed at:2026-06-01 06:00:42 UTC
