Medical Diode Laser Systems

Wuhan Dimed Laser Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

3

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

K211977 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K211977 as a predicate