CO2 Laser System

Smedtrum Medical Technology Co., Ltd.

Country / region:Taiwan (TW)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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1

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Device details

FDA 510(k) registration fields

K number
K221597
Device name
CO2 Laser System
Country / region
Taiwan(TW)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-06-02
Decision date
2022-09-15
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The CO2 Laser System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

Intended Use

The CO2 Laser System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

Device Description

CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch. CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 nm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application. When the laser contacts human tissue, the laser energy is absorbed by water in the target tissue, resulting in a very rapid, highly localized temperature increase to the tissue. The instantaneous temperature-increase heats up the water and causes evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the treatment area, causing tissue coagulation which induces hemostasis as well as thermal stimulation of deep skin layers, that inducing fibroblast stimulation and neocollagenesis. The CO2 Laser System is capable of producing continuous-wave, pulsed laser or fractional laser radiation. The physician can optimize the parameter for different applications by adjusting the energy of laser pulse and output pattern.

Summary parsed at:2026-06-01 05:40:07 UTC

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