Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The subject Lumenis M22 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 Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 different filters) is indicated for: • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos • Cutaneous lesions, including warts, scars and 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 • 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 • Mild to moderate inflammatory Acne (Acne vulgaris) 2. The Nd:YAG Laser handpiece 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. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: • Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue 4. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: • Removal of dark tattoos • Treatment of pigmented lesions *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.
The subject Lumenis M22 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 Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 different filters) is indicated for: • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos • Cutaneous lesions, including warts, scars and 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 • 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 • Mild to moderate inflammatory Acne (Acne vulgaris) 2. The Nd:YAG Laser handpiece 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. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: • Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue 4. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: • Removal of dark tattoos • Treatment of pigmented lesions *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.
The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces: • Universal Intense Pulsed Light (IPL) handpiece (K083733) • Multi-Spot Nd:YAG laser handpiece (K083733) • ResurFX non-ablative laser handpiece (K130028) • Q-Switched Nd:YAG laser handpiece (K043173)
Summary parsed at:2026-06-01 06:10:23 UTC
