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510(k) Data Aggregation
K Number
K233760Device Name
Mjolnir Pro. (Multielectrode plasma)
Manufacturer
Shenzhen Leaflife Technology Co., Ltd
Date Cleared
2024-02-20
(88 days)
Product Code
QVJ
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Leaflife Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.
Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.
Device Description
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316 stainless steel is available with the system.
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K Number
K230362Device Name
Planar LED mate
Manufacturer
Shenzhen Leaflife Technology Co., Ltd
Date Cleared
2023-09-11
(213 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Leaflife Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.
Device Description
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair. It utilizes a diode LED as a light source (780-850 nm). lt works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its emission activation is by finger switch.
The device contains a capacitive sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light. The device is for single-person use only.
The proposed Planar LED mate is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
The device has 5 level Output Intensity.
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K Number
K220103Device Name
LED Therapy Device (Planar LED/Planar LED mini)
Manufacturer
Shenzhen Leaflife Technology Co., Ltd
Date Cleared
2022-04-12
(90 days)
Product Code
GEX, OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Leaflife Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LED Therapy Device is intended for hair removal, permanent hair reduction on all skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
The LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece.
The proposed LED Therapy Device is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
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K Number
K212697Device Name
Leaf Smooth
Manufacturer
Shenzhen Leaflife Technology Co., Ltd
Date Cleared
2021-11-19
(86 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Leaflife Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
The Leaf Smooth (LH-LIPLB) 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. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon Arc Flashlamp, capacitive sensor to detect appropriate skin contact and a skin sensor to detect appropriate skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. The Leaf Smooth has 6 levels output intensity.
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K Number
K202980Device Name
Laser Therapy Device
Manufacturer
Shenzhen Leaflife Technology Co., Ltd
Date Cleared
2020-11-19
(50 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Leaflife Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Therapy Device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
The Laser Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser source (808 nm). The laser power is delivered to the treatment area via a laser hand piece. The emission laser is activated by a foot switch and a hand piece. The components of the Laser Therapy Device are mainly including main unit, hand piece, watered cup, overflow tube, foot switch, key, interlock, power cord, fuse, glasses and blindfold, etc.
The proposed Laser Therapy Device is equipped with laser depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex and hair cuticle). The laser can precisely target at the melanin and apply the depilation treatment selectively. After the melanin absorbs laser energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
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