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510(k) Data Aggregation
K Number
K221083Device Name
Smartlux Mini
Manufacturer
MEDMIX Co., Ltd.
Date Cleared
2022-07-12
(90 days)
Product Code
GEX, ILY
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDMIX Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blue (415-425mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (630-640nm) and Infrared (820-830mm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Device Description
The Photo-Therapy Device SMARTLUX MINI is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:
- · Red (630-640nm)
- · Blue (415-425nm)
- · Yellow (585-595nm)
- Infra-red (820-830nm)
This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.
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K Number
K120460Device Name
SMARTLUX
Manufacturer
MEDMIX CO., LTD
Date Cleared
2012-10-01
(229 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEDMIX CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions
415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
830nm wave length : the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Device Description
SMARTLUX is light therapy system using two kinds of wave length light and infrared ray. It has four type of head which is including red, blue and IR respectively. Heads are chanqeable by user and assembled head is identified automatically after changing head and user interface is also changed according to each head. For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software.
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