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510(k) Data Aggregation
K Number
K230060Device Name
Light Based Hair Removal Device GP592
Manufacturer
Shenzhen GSD Tech Co., Ltd.
Date Cleared
2023-03-03
(53 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen GSD Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
Device Description
The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.
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K Number
K213225Device Name
Diode Laser System GP900A8, Diode Laser System GP900Q8
Manufacturer
Shenzhen GSD Tech Co., Ltd.
Date Cleared
2021-12-22
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen GSD Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent 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 procedure. 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 GP90008 is a desktop case.
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K Number
K202827Device Name
308nm Excimer UV-light Skin Therapy System
Manufacturer
Shenzhen GSD Tech Co., Ltd.
Date Cleared
2020-12-15
(82 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen GSD Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 308nm Excimer UV-light Skin Therapy System is intended to the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Device Description
The 308nm Excimer UV-light Skin Therapy System is ultraviolet light emitting medical device.
The model GP908B is a desktop device, consisting of a main body, handpiece, footswitch and power cord.
The model GP908D is a handheld device, consisting of a main body, power cord and adapter.
308nm Excimer UV-light Skin Therapy System is designed to be used in dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. Users can set the device parameter and determine the machine's state and function on the control touch screen.
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K Number
K191518Device Name
CO2 Laser System
Manufacturer
Shenzhen GSD Tech Co., Ltd
Date Cleared
2019-09-12
(97 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen GSD Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
Device Description
The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.
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K Number
K180383Device Name
Light based hair removal device
Manufacturer
Shenzhen GSD Tech Co., Ltd
Date Cleared
2018-05-11
(88 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen GSD Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
Device Description
The Light based hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.
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