Ivylaser (Beijing) Technology Co.,Ltd
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick I-VI) including tanned skin. 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.
Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick I-VI) including tanned skin. 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 device operates at a wavelength of 810nm, with energy density for HR mode ranging from 2J/cm to 60J/cm and for FHR mode from 2J/cm to 10J/cm. It features two operation models: HR and FHR, with a spot size of 2 cm². The laser type is Diode Laser, with a pulse width of 5ms to 200ms, and frequency for HR mode is 1-3Hz and for FHR mode is 5-10Hz. The cooling methods include water and air. The device weights 60Kg and 33Kg, with sizes for Night Universe at 350mm x 450mm x 1000mm and for Predator at 500mm x 600mm x 500mm. Differences in size and weight do not affect the safety and effectiveness of the product.
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The Alma Soprano Titanium
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