Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Magma System is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and 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 430-1100nm is indicated for: HR, F-HR, B-HR Applicators (650-1100nm): • 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 (590-1100nm): • 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 (530-1100nm): • 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 (430-1100nm): • Mild to moderate inflammatory Acne (Acne vulgaris).
The Magma System is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and 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 430-1100nm is indicated for: HR*, F-HR*, B-HR* Applicators (650-1100nm): • 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 Magma System is a computerized multi-application, multi-technology platform, intended for non-invasive aesthetic applications utilizing laser and Intense Pulsed Light (IPL) optical power. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including a LCD display and touch screen module. Apart from the system platform the Magma System is provided with 13 applicators divided into three technology related sub-categories: • ALD & LLD Diode laser (808nm) Applicators for hair removal treatments. • Multi-spot Nd:YAG laser (1064nm) Applicator for coagulation and hemostasis of vascular lesions and soft tissue, hair removal treatments and non-ablative treatment of facial wrinkles. • Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories: o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V). o HR, F-HR & B-HR (590-1100nm) Applicators for hair removal treatments (skin types I-IV). o SR, F-SR & B-SR (530-1100nm) Applicators for the treatment of pigmented and vascular lesions. o F-AC (430-1100nm) Applicator for acne treatments. The operator chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the Magma System. The Magma System has two applicator ports; one for IPL based applicators and one for Laser applicators. The ports must be simultaneously connected with both laser and IPL applicators for the system to operate.
Summary parsed at:2026-06-01 06:05:32 UTC
