Device Dossier

Skin contouring system applicator tip, radio-frequency

Device Dossier for Skin contouring system applicator tip, radio-frequency (Skin contouring system applicator tip, radio-frequency, Class IIa, sponsor…

Intended purpose

A disposable single-use radio frequency applicator tip to connect to a radio-frequency handpiece to regulate the delivery of RF energy to the patient during treatment. For noninvasive external use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. For noninvasive external use for the temporary relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. For use in dermatological procedures requiring ablation and resurfacing of the skin. Radiofrequency accessories are not intended for gynaecological procedures including but not limited to the treatment of stress urinary incontinence (SUI), labioplasty, sexual dysfunction, pelvic floor weakness, genitourinary syndrome of menopause (GSM) or vulvovaginal atrophy (VVA), changes in aesthetic appearance of the female anatomy, dryness, itching, reduced elasticity, and burning during menopause.

TGA Public Summary