Manufacturer
Xuzhou Kernel Medical Equipment Co., Ltd.LED Light Therapy Device, KN-7000L
Xuzhou Kernel Medical Equipment Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K222751
- Device name
- LED Light Therapy Device, KN-7000L
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-09-12
- Decision date
- 2023-02-01
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Skin resurfacingAcne treatmentPigment treatmentVascular treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
LED Light Therapy Device use of the red, blue, yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (835±15nm wavelength) is generally used 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
LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light (633410nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417+10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (599+10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (835+15nm wavelength) is generally use 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 Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light Emitting Diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10nm), yellow light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm). The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light). The instrument is mainly composed of a main frame, an irradiator, and a lifting stand. Light source is extensible according to the areas to be treated to realize large-area irradiation. Light source is arranged in matrix, making it more suitable for facial treatment. Fixing and electrical connection of the light source is realized through a quick connector, making the replacement more convenient and fast. Design of free-lifting cantilever allows the light source to stay at any position and angle. 10.4" touch screen simplifies the operation and eliminates the need for professional training. 5 commonly used treatment schemes can be stored to avoid repeated setting. Warm voice guide makes it easy for you to operate. Effective irradiance of the light source can be adjusted according to the treatment need. Double switch protection of power switch and power-on password, no need to worry about being misused. Non-invasive operation, no damage to skin cells. No special care is required after treatment, and makeup can be applied normally.
Summary parsed at:2026-06-01 05:31:59 UTC
Predicate devices
2Phototherapy System
Oxylight
K222751 references 2 predicate/reference devices
Cited as predicate
4Phototherapy System (OL-PDT950)
FlashHeal 2 (FlashHeal 2.0)
LED Light Therapy Device, ELIXIR MD™
Photon Therapy Apparatus (BL-10)
4 submissions cite K222751 as a predicate
