Shenzhen Ishine Technology Company Limited
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
IPL Hair Removal 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.
IPL Hair Removal 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.
IPL Hair Removal Device (Models: skn001, skn005, skn006, skn002, RoseSkinCo Lumi) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact; if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. IPL Hair Removal Device, models: skn001, skn005, skn006 have the same indication for use, performance, structure design and operation, the only difference is their appearance and weight. Model skn002 is not only different in appearance and weight, but the output intensity level is different (with 6 levels). Model RoseSkinCo Lumi is identical to skn002 and only different in model names.
Summary parsed at:2026-06-11 04:35:01 UTC
