# K212318: IPL Hair Removal

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Define Beauty Electronic Technology Co., Ltd.
- Decided: Jan 14, 2022 after 172 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K950019 (1995). 57 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181568: IPL Salon Hair Reduction System, Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt (2018) Summary page 4.

## Most influential descendants
- K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C (2022), 25 descendants of its own
- K230360: IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02 (2023), 17 descendants of its own
- K231717: IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 (2023), 11 descendants of its own
- K240016: IPL Hair Removal Device (YT01,YT02,YT03,YT04) (2024), 9 descendants of its own
- K241998: Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) (2024), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K212318
Methodology: https://510kreport.com/methodology