Diode Laser System GP900A8, Diode Laser System GP900Q8

Shenzhen Gsd Tech Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K213225
Device name
Diode Laser System GP900A8, Diode Laser System GP900Q8
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

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