Manufacturer
Weifang Mingliang Electronics Co., Ltd.Medical Diode Laser Hair Removal System
Weifang Mingliang 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
- K200525
- Device name
- Medical Diode Laser Hair Removal System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-03-02
- Decision date
- 2020-05-27
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Intended Use
The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Device Description
Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through an LCD touch-screen. In the handpiece of the machine, the light emitted by each discharge at 808nm.
Summary parsed at:2026-06-01 05:47:52 UTC
Predicate devices
2Spirit Hair Removal laser Family
Diode Laser System
K200525 references 2 predicate/reference devices
Cited as predicate
3Diode Laser Hair Removal System (MBT-Diode Laser)
Diode Laser Hair Removal System
Nd: YAG Laser Therapy Systems
3 submissions cite K200525 as a predicate