Device Dossier

Celluma Series 2 - Blue/red/infrared phototherapy lamp

Device Dossier for Celluma Series 2 - Blue/red/infrared phototherapy lamp (Blue/red/infrared phototherapy lamp, Class IIa, sponsor Emergo). ARTG record,…

Intended purpose

In ACNE Mode, the blue LEDs are dominant and the red and near infra-red LEDs are on but at a low level. The device in this mode is used to treat mild to moderate acne vulgaris. In WRINKLES Mode, red, blue, and infra-red wavelengths are intended to be used as a non-invasive dermatological aesthetic management of facial wrinkles. In ACHES and PAINS Mode, the device emits red and near infrared light to provide topical heating for the purpose of elevating tissue temperature for the treatment of low back pain and fibromyalgia. In HAIR mode, the devices are intended to emit energy in the red region of the spectrum to the scalp to promote hair growth in people with androgenic alopecia. In CONTOUR mode, the devices red and near infrared light is intended to be used as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, thighs, and waist.

TGA Public Summary