Manufacturer
Xemis Medical Technology (Shenzhen) Co., Ltd.Photon Therapy Apparatus (BL-10)
Xemis Medical Technology (Shenzhen) 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
- K243993
- Device name
- Photon Therapy Apparatus (BL-10)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-12-26
- Decision date
- 2025-03-13
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatmentSkin tighteningOther
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
Photon therapy apparatus 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±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (830±8nm 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
Photon therapy apparatus 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±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (830±8nm 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 photon therapy apparatus (BL-10) use 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±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm). The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources.
Summary parsed at:2026-06-01 05:21:56 UTC
Predicate devices
3Phototherapy System
Oxylight
LED Light Therapy Device, KN-7000L
K243993 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K243993 as a predicate
