# K251176: IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mlay Intelligent Technology Co.,, Ltd.
- Decided: Aug 14, 2025 after 120 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: 24 generations back to K950019 (1995). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241106: Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A), Shenzhen Mlay Intelligent Technology Co.,, Ltd. (2024) Summary page 5.
- K223928: Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K, Shenzhen Fansizhe Science and Technology Co., Ltd. (2023) Summary page 5.
- 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.
- K230122: IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG, Shenzhen Ulike Smart Electronics Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K253666: IPL Hair Removal Device (Models: T31A, T32A) (2026), 0 descendants of its own

## Indications for use
The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K251176
Methodology: https://510kreport.com/methodology