Manufacturer
San HE Lefis Electronics Co., Ltd.Diode Laser Therapy System
San HE Lefis 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
- K192569
- Device name
- Diode Laser Therapy System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-18
- Decision date
- 2019-12-13
- 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 Therapy 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 Therapy 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 proposed device, Diode Laser, is a surgical device intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The power system includes a network power supply, laser power supply system, refrigeration power supply system, and auxiliary power supply system. The power lines and rocker switch control the on-off of the hair removal instrument with the outside power supply. The key switch and emergency stop switch control the on-off of network power, providing work current for the microprocessor control system, touch screen operation display system, and other functional components. The power system has a self-protection function, notifying users through the touch screen interface in case of errors. The microprocessor control system automates the operation, performing self-checks and calling treatment parameters. The operation display system consists of a touch screen, indicator, and buzzer, allowing the operator to control the microprocessor and monitor the device state and parameters.
Summary parsed at:2026-06-01 05:56:01 UTC
Predicate devices
2Diode Laser Hair Removal System
Diode Laser System
K192569 references 2 predicate/reference devices
Cited as predicate
1Dermatological Diode Laser Systems
1 submission cite K192569 as a predicate
