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510(k) Data Aggregation
K Number
K192642Device Name
308nm Excimer System
Manufacturer
Chongqing Peninsula Medical Technology Co., Ltd.
Date Cleared
2020-05-13
(232 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Peninsula Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.
Device Description
The 308nm Excimer System (model: XECL-308E)is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). The system including a main body, power line, handpiece holder, XeCl lamp, handpiece, and output light window adapter. The handpiece includes a contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength mainly between 308±2 nm. The device should be operated by a professional doctor in the hospital for the treatment.
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K Number
K192552Device Name
Irradiation Cosmetic Device
Manufacturer
Chongqing Peninsula Medical Technology Co., Ltd.
Date Cleared
2020-04-17
(213 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Peninsula Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Irradiation Cosmetic Device (Model: HairPro Plus) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
Device Description
Irradiation Cosmetic Device (Model: HairPro Plus) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.
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K Number
K172273Device Name
308nm Excimer System
Manufacturer
Chongqing Peninsula Medical Technology Co., Ltd.
Date Cleared
2018-07-30
(367 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Peninsula Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Device Description
308nm Excimer System is an ultratraviolet light system 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 wavelenath of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.
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K Number
K171835Device Name
Irradiation Aesthetic Device
Manufacturer
Chongqing Peninsula Medical Technology Co., Ltd.
Date Cleared
2018-01-30
(224 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Peninsula Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
Device Description
Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.
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