Manufacturer
Smedtrum Medical Technology Co., Ltd.CO2 Laser System
Smedtrum Medical Technology Co., Ltd.
Country / Region:Taiwan (TW)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
Predicate devices
1CO2 Laser Therapy System
K221597 references 1 predicate/reference device
Cited as predicate
1Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
1 submission cite K221597 as a predicate
