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510(k) Data Aggregation
K Number
K180193Device Name
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
Manufacturer
El.En Electronic Engineering S.p.A.
Date Cleared
2018-02-21
(28 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
El.En Electronic Engineering S.p.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Incision, excision, ablation, vaporization 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.
Device Description
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.
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