Darwin

The device is intended for use in dermatologic and general surgical procedures. The Diode Laser handpiece is indicated for:
• The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin.

The IPL Handpiece is indicated for:
• Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis.

The Diode Laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece. The IPL Handpiece is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The RF Microneedling handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 3 handpieces that are attached to the console, and through the user interface can be selected for use in the treatments. Each handpiece has its own indication for use: Diode Laser Handpiece, IPL Handpiece, and RF Microneedling Handpiece.