Device Dossier

Skin surface treatment system generator

Device Dossier for Skin surface treatment system generator (Skin surface treatment system generator, Class IIb, sponsor Sciton). ARTG record, intended…

Intended purpose

Sciton BBL/s Systems and Accessories are indicated for use in surgical applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. The treatment of cutaneous lesions including warts, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, venous malformations, psoriasis, vitiligo, atopic dermatitis (eczema), sebhorreic dermatitis, mild to moderate inflammatory and pustular inflammatory acne vulgaris, topical heating for the purpose of elevating tissue temperature and to promote increased blood flow for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis. In addition it may also help minor sprains and strains, and minor muscular back pain. The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling). Reduce discomfort during and/or associated with light or laser treatment. Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation. Allow the use of higher fluences and reduce potential side effects of light treatments.

TGA Public Summary