# K250384: IPL400

- Pathway: 510(k) (Traditional)
- Applicant: El Global Trade, Ltd.
- Decided: May 23, 2025 after 101 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: 26 generations back to K950019 (1995). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242039: Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR), Shenzhen Ulike Smart Electronics Co., Ltd. (2024) Summary page 5.
- K130315: Ipulse Hair Removal System, Cyden Limited (2013) Summary page 5.
- K240016: IPL Hair Removal Device (YT01,YT02,YT03,YT04), Shenzhen Jianrong Biomedical Electronics Co., Ltd. (2024) Summary page 5.

## Indications for use
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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.

Source page: https://510kreport.com/device/K250384
Methodology: https://510kreport.com/methodology