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 Ebos Medical Devices).…
- GMDN category: Multi-modality skin surface treatment system
- Sponsor: Ebos Medical Devices
Intended purpose
The FRAXIS DUO system combines a fractional CO2 laser and micro-needle fractional RF for the treatment of acne scars, aging skin lesions and various skin renewal and rejuvenation applications, as well as hyperhidrosis. The laser system and its accessories are not intended for gynaecological procedures including but not limited to the treatment of diminished sensation during intercourse; dryness, loss of lubrication and pain during intercourse; vaginal pain or discomfort; vaginal laxity (looseness) and trophy, urinary incontinence and urgency, vaginal itchiness and discomfort, vulva tightening and lightening, and recurrent thrush.