Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It 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 re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It 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 re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord. It is used AC Powered (100-240 V AC; 50/60 Hz). The weight of the device is 650g, and the size is 143 x 69.5 x 43mm (H*W*D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Summary parsed at:2026-06-11 04:24:43 UTC
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9 submissions cite K181568 as a predicate
