Manufacturer
Shenzhen Gsd Tech Co., Ltd.Diode Laser System GP900A8, Diode Laser System GP900Q8
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
- K213225
- Device name
- Diode Laser System GP900A8, Diode Laser System GP900Q8
- 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
- 2021-09-29
- Decision date
- 2021-12-22
- 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 System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I-V), 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 System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Diode Laser 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 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 (810 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 System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 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 mode. The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP900Q8 is a desktop case.
Summary parsed at:2026-06-01 05:44:00 UTC
Predicate devices
1DIODE LASER HAIR REMOVAL SYSTEM
K213225 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K213225 as a predicate
