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510(k) Data Aggregation
K Number
K142186Device Name
DIODE LASER HAIR REMOVAL SYSTEM
Manufacturer
SHENZHEN GSD TECH. CO., LTD.
Date Cleared
2015-04-17
(252 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 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-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 regiment
Device Description
The diode laser hair removal 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 (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 GP900O. 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.
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K Number
K091664Device Name
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
Manufacturer
SHENZHEN GSD TECH. CO., LTD.
Date Cleared
2009-11-16
(160 days)
Product Code
ONF
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 GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:
1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
2. Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
3. Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.
Device Description
The GSD Intense Pulsed Light System (GP666C4 and GP666C) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
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