Manufacturer
Wuhan Dimed Laser Technology Co., Ltd.Medical Diode Laser Systems
Wuhan Dimed Laser Technology Co., Ltd.
Country / Region:China (CN)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
- K211977
- Device name
- Medical Diode Laser Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-06-25
- Decision date
- 2021-10-26
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The "CHERYLAS-1I5N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Intended Use
The "CHERYLAS-1I5N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Device Description
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber. The block diagram shows how the diode laser system works. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system. The system can test and calibrate power by the calibration and feedback unit.
Summary parsed at:2026-06-01 05:43:24 UTC
Predicate devices
2—
—
Not ingested
MEDICAL DIODE LASER SYSTEMS
K211977 references 2 predicate/reference devices
Cited as predicate
3Medical Diode Laser, Model S1Pro
Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
Medical Diode Laser Systems (VeinCure)
3 submissions cite K211977 as a predicate
