# K251398: IPL Hair Removal Device (IPL-001, IPL-002)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Enmind Technology Co., Ltd.
- Decided: Oct 2, 2025 after 149 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). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230122: IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG, Shenzhen Ulike Smart Electronics Co., Ltd. (2023) Summary page 5.
- K242710: Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), Shenzhen Jianchao Intelligent Technology Co., Ltd. (2024) Summary page 5.
- K130315: Ipulse Hair Removal System, Cyden Limited (2013) Summary page 5.

## Indications for use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial 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/K251398
Methodology: https://510kreport.com/methodology