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

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

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

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