Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The SMARTXIDE PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, 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.
The SMARTXIDE PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, 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.
SmartXide PRO is a 10.6µm carbon dioxide laser (CO2 laser), which is highly absorbed by water. Since tissue is comprised mostly of water, this invisible wavelength is highly effective in the surgical treatment of soft tissues. Moreover, SmartXide PRO device can be equipped with a scanning unit, called HiScan DOT, which can be connected to the arm to provide high performance in specific fields. The scanning unit is intended for fractionated skin resurfacing or traditional skin resurfacing. The modifications to the device consist of a restyling of the device (chassis, cover plastic, dimensions, weight, plastic cover, CPU and GUI), a restyling of HiScan DOT unit. The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since.
Summary parsed at:2026-06-01 05:27:45 UTC
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