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…
- GMDN category: Intense pulsed light skin surface treatment system
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.