Device Dossier
3JUVE - Multi-modality skin surface treatment system
Device Dossier for 3JUVE - Multi-modality skin surface treatment system (Multi-modality skin surface treatment system, Class IIb, sponsor Professional…
- GMDN category: Multi-modality skin surface treatment system
Intended purpose
The 3JUVE IPL, laser and RF system is intended for use in applications requiring the selective photothermolysis of soft issue in the medical specialties of general & plastic surgery and dermatology. The 3JUVE System, when using the Rebright IPL Handpieces, is indicated for: - The treatment of benign pigmented epidermal lesions including dyschromia, lentigines and ephelides (freckles) - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - The treatment of mild to moderate acne - The removal of unwanted hair when being carried out as part of the treatment for Polycystic Ovary Syndrome (PCOS), pilonidal sinus or pseudofolliculitis barbae The 3JUVE System, when using the Resurface Fractional Er:YAG Laser Accessory at 2940nm, is indicated for : - Scaring: Acne scars, surgical scars, traumatic scars