Manufacturer
Wingderm Electro-Optics , Ltd.Diode Laser Therapy Systems
Wingderm Electro-Optics , Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K191611
- Device name
- Diode Laser Therapy Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-06-17
- Decision date
- 2019-07-31
- 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 Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 Therapy Systems has one model WLA-01, which mainly consists of the main console, treatment hand piece and a foot switch. The treatment hand piece consists of the laser aperture, laser emission indicator, laser emission and hand piece display screen. The main console consists of power switch, hand piece holder, LCD touch screen, emergency shut off, hand-grip grab bar, connector hand piece, access door, observation window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain and fans. The device has an embedded software named Diode Laser Therapy Systems Control Software. The principle of laser hair removal is selective photothermolysis, 808nm wavelength effectively penetrates deep into and is absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal. The laser window of the hand piece will contact the skin directly and the laser output will contact the skin through the window. The Diode Laser Therapy System is suitable for use in healthcare facility/hospital. Only trained personnel who have been trained in the use of laser products and clinical training should be able to use this product for treatment.
Summary parsed at:2026-06-01 05:55:34 UTC
Predicate devices
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DIODE LASER THERAPY SYSTEMS
K191611 references 2 predicate/reference devices
Cited as predicate
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