Manufacturer
Weifang KM Electronics Co., Ltd.Diode Laser Treatment System
Weifang KM Electronics 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
- K182924
- Device name
- Diode Laser Treatment System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-10-19
- Decision date
- 2019-04-15
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Diode Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Intended Use
The Diode Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
The Diode Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The device provides 36 working modes, which are six modes for men and six modes for women. The men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.
Summary parsed at:2026-06-01 05:54:44 UTC
Predicate devices
2—
—
Not ingested
Diode Laser Therapy Machine
K182924 references 2 predicate/reference devices
Cited as predicate
2Laser Treatment System, Model: NYX and Grace
Diode Laser Therapy Systems
2 submissions cite K182924 as a predicate
