Dongguan Define Beauty Electronic Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The IPL HAIR REMOVAL (Model: SG-8025) 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 HAIR REMOVAL (Model: SG-8025) 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 HAIR REMOVAL SG-8025 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. 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. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.
Summary parsed at:2026-06-11 04:29:55 UTC
IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
K212318 references 1 predicate/reference device
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
4 submissions cite K212318 as a predicate
