Device Dossier
Dermatological carbon dioxide laser system
Device Dossier for Dermatological carbon dioxide laser system (Dermatological carbon dioxide laser system, Class IIb, sponsor Ebos Medical Devices). ARTG…
- GMDN category: Dermatological carbon dioxide laser system
- Sponsor: Ebos Medical Devices
Intended purpose
FRAXIS is a surgical dermatological carbon dioxide laser system used to conduct microfractional laser resurfacing, promoting the reconstruction of both epidermis and dermis. Its uses include the treatment of acne scars, aging skin lesions and various skin renewal and rejuvenation applications. 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.