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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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