Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS

The Simultaneous Triple Wavelength Handpiece (755/808/1064) nm is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include:
● Benign vascular and vascular dependent lesions removal.

The indications for use for the Handpiece of 1064 nm:
● The Hair Removal is intended for permanent reduction in hair regrowth defined as a 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.
● Treatment of Pseudo folliculitis Barbae (PFB)
● Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The indications for use for the handpiece of 808 nm:
● The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a 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.
● The treatment of benign vascular and pigmented lesions.
● Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The indications for use for the Handpiece of 755 nm:
● The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a 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.
● The treatment of benign vascular and pigmented lesions.
● Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The device is intended for use in dermatologic and general surgical procedures. The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal. The indications for use for the handpiece of 1064nm include: The Hair Removal is intended for permanent reduction in hair regrowth defined as a 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. Treatment of Pseudo folliculitis Barbae (PFB). Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the handpiece of 808 nm include: The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a 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. The treatment of benign vascular and pigmented lesions. Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the handpiece of 755 nm include: The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a 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. The treatment of benign vascular and pigmented lesions. Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The device includes four models for clearance in this submission. The differences between models are on their appearance and number of the connectors. The proposed device is intended to use for hair removal on all skin types and Benign Vascular lesions and vascular dependent lesions removal.