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 Esthetica Academy).…
- GMDN category: Multi-modality skin surface treatment system
Intended purpose
Intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue and skin, and for skin resurfacing procedures. Uses include permanent hair removal, reduction of pigmented lesions, tattoo removal, reduction of vascular lesions, acne therapy, treatment of wrinkles, acne and surgical scars, and textural irregularities. This includes the treatment of skin conditions and lesions such as, but not limited to, melasma, striae, vascular dyschromia, port wine stains, hemangiomas, telangiectasia, rosacea, venus lake, leg veins, spider veins, pseudofolliculitis barbae.