Device Dossier
Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
Device Dossier for Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system (Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system, Class IIb,…
- GMDN category: Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
- Sponsor: Ebos Medical Devices
Intended purpose
Indicated for: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific indications: - Tattoo Removal, Dermal Pigmented Lesions, Nevus of Ota, Removal or lightening of hair with or without adjuvant preparation, Skin Resurfacing for Acne Scars and Wrinkles; - Vascular lesions including but not limited to: telangiectasias, spider angioma, cherry angioma, spider nevi, Epidermal Pigmented lesions including but not limted to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker’s nevi, Freckles, Nevus spilus; - Benign cutaneous lesions, such as, but not limited to: striae and scars - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.