Manufacturer
Shenzhen Gsd Tech Co., Ltd.DIODE LASER HAIR REMOVAL SYSTEM
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
- K142186
- Device name
- DIODE LASER HAIR REMOVAL SYSTEM
- Company
- Shenzhen Gsd Tech Co., Ltd.
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-08-08
- Decision date
- 2015-04-17
- 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 Hair Removal System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Intended Use
The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
The diode laser hair removal system is a surgical device intended for use in dermatologic and general surgical procedures. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed diode laser removal system has two models, GP900A and GP900Q. Both GP900A and GP900Q have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free setting mode. The GP900A is a standard case with wheels to allow easy movement on the floor. The GP900Q is a desktop case.
Summary parsed at:2026-06-01 06:10:19 UTC
Predicate devices
1—
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Not ingested
K142186 references 1 predicate/reference device
Cited as predicate
1Diode Laser System GP900A8, Diode Laser System GP900Q8
1 submission cite K142186 as a predicate
