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510(k) Data Aggregation
K Number
K251076Device Name
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
Manufacturer
Date Cleared
2025-07-30
(113 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Lifotronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.
Device Description
The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.
The wand can be rotated 135 degrees in either direction.
There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.
The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.
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K Number
K192466Device Name
Air Compression Therapy System
Manufacturer
Date Cleared
2020-06-22
(287 days)
Product Code
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Lifotronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Airpro-690 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.
Device Description
Air Compression System include the host, sleeves, and the air tube to connect them together. Through a multi-chamber inflatable sleeve orderly conducting of rhythmic squeezing inflation and deflation, it cyclic pressure on limb tissue, so as to promote venous blood return, enhance arterial infusion, improve blood circulation and lymphatic circulation. Two port on the back of the controller, labeling as Channel 1/2. And four air ways on each channel. The two channels can work independently, or simultaneously. The system can identify the channel and type of wearing sleeves automatically. If two channels were connected with sleeves, the system will inflate 1/2 channel simultaneously. Treatment Time, pressure, Channel and Treatment Mode are all can be adjusted on Parameter Settings Interface of the main unit.
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