Phototherapy System

Shanghai Apolo Medical Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

5

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

K190938 references 1 predicate/reference device

Cited as predicate

5

5 submissions cite K190938 as a predicate