Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
EmoLED is a portable, reusable medical device powered by rechargeable lithium-ion batteries that illuminate six (6) LED light sources which emit non-coherent blue light between 415 ± 5 nanometers (nm). The EmoLED device emits a uniform and constant optical power intensity of 120 mW/cm2 over an area of approx. 50.3 cm2 (a circle of 8 cm in diameter) at a distance of 4 +/- 1 cm. The EmoLED device consists of: a polycarbonate body containing a software-controlled processor that controls the emission of light; a touch screen (display), placed in the front part of the body of the device that allows the operator to control the device; a multi-function (on/off) button, placed in the posterior part of the body of the device; a power jack and a micro-USB plug, placed on the left side of the body of the device; an optic part containing the LED light source, the LED's control board, an optical lens (optic head) and a distance sensor connected to the body which can be rotated by the operator up to 180 degrees to project the light beam on the desired skin surface; accessories, which include a visual comfort screen and 24V power supply (with an integrated connection cable).
Summary parsed at:2026-06-01 05:27:20 UTC
