Device Dossier

Electrosurgical system, general-purpose

Device Dossier for Electrosurgical system, general-purpose (Electrosurgical system, general-purpose, Class IIb, sponsor Ebos Medical Devices). ARTG…

Intended purpose

Electrtosurgical system with a variety of applications both aesthetic and surgical procedures. Aesthetic procedures - for non-ablative treatment of mild to moderate facial wrinkles and rhytids. - provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide a temporary reduction in the appearance of cellulite Surgical Procedures - Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed. - Cutting: snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, and blepharoplasty. - Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development of skin flaps. Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. - Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any, field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage

TGA Public Summary