Device Dossier

General/multiple surgical carbon dioxide laser system

Device Dossier for General/multiple surgical carbon dioxide laser system (General/multiple surgical carbon dioxide laser system, Class IIb, sponsor…

Intended purpose

Fractional CO2 Laser Machine is used in medical institutions for the treatment of skin warts (common warts, flat warts, plantar warts, verrucous epidermal dysplasia, etc.) by vaporizing, carbonizing, coagulating, and irradiating human tissues. This device is not intended for use in gynecological conditions or for cosmetic dermatology indications such as acne treatment, wrinkle improvement, or removal of pigmented lesions .