Manufacturer
Shenzhenshi Sincoheren S&T Development Co., Ltd.LED Spectrum therapy instrument
Shenzhenshi Sincoheren S&T Development Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K231894
- Device name
- LED Spectrum therapy instrument
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-28
- Decision date
- 2023-09-20
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Acne treatmentSkin resurfacingSkin tighteningOther
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, PDT-M. PDT-I: - Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. - Combination of Red (630±10nm) and Infrared (825±10nm) 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 Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-J: - Combination of Yellow (590±10nm) and Infrared (825±10nm) 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. - Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-K: - Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. - Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-L: - Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-M: - Combination of Yellow (590±10nm) and Infrared (825±10nm) 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.
Intended Use
The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, PDT-M. PDT-I: Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10nm) and Infrared (825±10nm) 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 Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-J: Combination of Yellow (590±10nm) and Infrared (825±10nm) 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. Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-K: Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-L: Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-M: Combination of Yellow (590±10nm) and Infrared (825±10nm) 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 LED Spectrum therapy instrument 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±10nm), Blue (420±10nm), Yellow (590±10nm), Infrared (825±10nm). 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.
Summary parsed at:2026-06-01 05:33:07 UTC
Predicate devices
2—
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Not ingested
Smartlux Mini
K231894 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231894 as a predicate
