Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.Phototherapy System
Shanghai Apolo Medical Technology 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
- K190938
- Device name
- Phototherapy System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-04-10
- Decision date
- 2019-06-26
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Acne treatmentVascular treatmentPigment treatmentOther
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
Phototherapy Systems use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. - 415nm wavelength: specifically indicated to treat moderate inflammatory acne vulgaris. - 630nm wavelength: generally indicated for treatment of superficial, benign vascular, and pigmented lesions. - 830nm wavelength: intended for 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
Phototherapy Systems use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (630nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The infrared light (835nm 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 Phototherapy Systems HS-770 is a vertical device which 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 (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Three or four sets of LEDs panels are available for the device.
Summary parsed at:2026-06-01 05:55:17 UTC
Predicate devices
1—
—
Not ingested
K190938 references 1 predicate/reference device
Cited as predicate
5Dermalux Tri-Wave MD
Photodynamic Therapy (PDT) Equipment
LED Light Therapy Device, KN-7000L
FlashHeal 2 (FlashHeal 2.0)
Photon Therapy Apparatus (BL-10)
5 submissions cite K190938 as a predicate
