Device Dossier
Multi-modality skin surface treatment system
Device Dossier for Multi-modality skin surface treatment system (Multi-modality skin surface treatment system, Class IIb, sponsor InMode). ARTG record,…
- GMDN category: Multi-modality skin surface treatment system
Intended purpose
Radio frequency, intense pulsed light and laser systems for, - hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. - for the treatment of superficial vascular and pigmented lesions, vascular lesions, including leg veins, spider veins, and other benign vascular lesions for patients with skin type I to V. - use in dermatological procedures requiring ablating and resurfacing of the skin. - use in dermatologic procedures for noninvasive treatment of mild to moderate facial wrinkles and rhytides. - treatment of smaller zones as periorbital area, eye lids and upper lips. - treatment of symptoms of Dry Eye Disease due to Meibomian Gland Dysfunction. - non-invasive and non-ablative treatment of the tissue to trigger collagen remodeling for the treatment of wrinkles - temporary relief of minor muscle aches and pain, temporary relief of muscle spam, and temporary improvement of local blood circulation - temporary reduction in the appearance of cellulite. - temporary improvement of circumferential reduction and body contouring. Radiofrequency or laser 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.