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510(k) Data Aggregation
K Number
K243040Device Name
LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
Manufacturer
Shenzhen Siken 3D Technology Development Co., Ltd.
Date Cleared
2024-12-20
(84 days)
Product Code
OHS, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Siken 3D Technology Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Device Description
The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (620mm±10mm), blue (460±10nm) and infrared (850nm=10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller (Only for SKB-2318L,SKB-2318PRO, IN-FM002,SKB-2418) is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.
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K Number
K232845Device Name
IPL Cooling Hair Removal Device
Manufacturer
Shenzhen Siken 3D Technology Development Co., Ltd.
Date Cleared
2023-11-14
(61 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Siken 3D Technology Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The subject device IPL Cooling 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
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K Number
K222710Device Name
IPL Cooling Hair Removal Device
Manufacturer
Shenzhen Siken 3D Technology Development Co., Ltd.
Date Cleared
2022-12-01
(84 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Siken 3D Technology Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The subject device IPL Cooling 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
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K Number
K163470Device Name
Galvanic Spa, Model: SKB-1405
Manufacturer
ShenZhen Siken 3D Technology Development Co., Ltd.
Date Cleared
2017-06-02
(172 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ShenZhen Siken 3D Technology Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.
Device Description
Galvanic Spa, Model: SKB-1405 is a non-invasive facial toning device intended for facial stimulation. It produces micro-current discharged through the dual probes that are designed for optimal contact with faces of all shapes and sizes.Micro-current is an aesthetic modality providing electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying 0-390 μΑ.
Galvanic Spa, Model: SKB-1405 is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI). This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.
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