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Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Home Use Hair Removal Device is composed of a hand-held applicator and an external power supply. The spot size (treatment area) in the IPL Home Use Hair Removal Device is 3cm². The device contains a lamp, a skin proximity sensor. If the IPL Home Use Hair Removal Device is not properly applied (in full contact with the skin), the device will not trigger a pulse. The IPL Home Use Hair Removal Device includes FZ-608, FZ-608G, FZ-100, and FZ-200 four models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance, energy output range and its equipped power supply model. The model difference is embodied in: #1) energy output level of model FZ-608 and FZ-608G has 9 levels, corresponding to an output range of 4.16J~10J; model FZ-100 has 9 levels, corresponding to an output range of 5.7J~16.26J, and model FZ-200 has 6 levels, corresponding to an output range of 4.6J~13,5J; #2) the main unit FZ-608 and FZ-608G can be supplied by the power adaptor (model: SHCSP2402000FUS), and the main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.

IPL home use hair removal device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL home use hair removal device is also intended for permanent reduction in unwanted hair. 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 regimen. The device is used for adults with Fitzpatrick skin types I - IV.

The Hand-held IPL device are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photosynthesis in which optical energy is used to disable hair growth. The Hand-held IPL device devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Hand-held IPL device devices is 3 cm², The device contains a lamp, a skin proximity sensor. If the Hand-held IPL device is not properly applied (in full contact with the skin) , the Hand-held IPL device will not trigger a pulse. The main unit FZ-608 and FZ-608G can only be supplied by the power adaptor (model: SHCSP2402000FUS), The main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment. FZ-608 and FZ-608G are identical except for model No. and enclosure colour. The patient is an intended operator.