Device Dossier

Intense pulsed light skin surface treatment system

Device Dossier for Intense pulsed light skin surface treatment system (Intense pulsed light skin surface treatment system, Class IIb, sponsor Wiselink…

Intended purpose

The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.