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 Family of laser system are medical devices equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 30W/50W/60W. 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 Family laser is equipped with a Scanning Unit that allows to perform skin resurfacing treatments. The modifications to the devices are 1) different maximum available output power: 60W, 30W and 50W and 2) different external system and scanner covers for DEKA SmartXide Punto models. The intended use of the modified devices, as described in the labeling, has not changed as a result of the modifications.
Summary parsed at:2026-06-01 05:56:56 UTC
