Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The SmoothCool HR System is indicated for hair removal (permanent hair reduction). The SmoothCool HR System is indicated for hair removal (permanent hair reduction). The subject Stellar M22 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: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: - Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) - Cutaneous lesions, including warts, scars and striae - Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - Removal of unwanted hair 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) 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 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 ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: - Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: - Removal of dark tattoos - Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
The SmoothCool HR System is indicated for hair removal (permanent hair reduction). The subject Stellar M22 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: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles); cutaneous lesions, including warts, scars and striae; benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; removal of unwanted hair 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). 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 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. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: removal of dark tattoos; treatment of pigmented lesions. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
SmoothCool HR System is an Intense Pulsed Light (IPL) system used for hair removal (permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment. Four different hand pieces are offered with the system.
Summary parsed at:2026-06-01 05:39:00 UTC
