Magma System FDA Indications

 
 

The Magma System is indicated for use in aesthetic applications in dermatology The Magma System has connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

  1. The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction in skin types I-VI and for the treatment of Pseudofolliculitis Barbae  (PFB).
  2. The Magma System with Nd: YAG Laser Handpiece  (ND) with a wavelength of 1064 nm  (Multi-Spot Nd: YAG) is indicated for:
    • The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias  (venulectasias) and reticular veins  (0.1 - 4.0 mm. Diameter) of the leg .
    • The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles
    • The non-ablative treatment of facial wrinkles 
  3. The Magma System with the Intense Pulsed Light  (IPL) Handpieces  (10 different Applicators) with a spectrum of 430-1100 nm is indicated for:
    • HR*, F-HR, B-HR Applicators  (650-1 100 nm):
      • Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles HR, F-HR, B-HR Applicators  (590-1100 nm):
      • Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles.
    • SR, F-SR, B-SR Applicators  (530-1100 nm):
      • Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides  (freckles)
      • Cutaneous lesions, including striae
      • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
    • F-AC Applicator  (430-1100 nm):
      • Mild to moderate inflammatory Acne  (Acne vulgaris)

Note: 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 regime.