# K172883: Home Use Hair Removal Device/T1, T2, T3

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mareal Tech Co., Ltd.
- Decided: Feb 12, 2018 after 144 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: 18 generations back to K950019 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161428: PerfectSmooth, Shen Zhen Cosbeauty Co., Ltd. (2017) Summary page 4.
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 4.

## Indications for use
The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.

Source page: https://510kreport.com/device/K172883
Methodology: https://510kreport.com/methodology