# K220248: Home use hair removal device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mareal Tech Co., Ltd.
- Decided: Jul 1, 2022 after 151 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: 21 generations back to K950019 (1995). 60 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210311: Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7., Shenzhen Mismon Technology Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K240264: Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) (2024), 6 descendants of its own
- K241205: Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) (2024), 2 descendants of its own
- K241106: Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) (2024), 2 descendants of its own
- K251176: IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) (2025), 1 descendant of its own
- K250171: IPL Hair Removal Device (BE965A, BE965B, BE965C) (2025), 1 descendant of its own

## Indications for use
The Home use hair removal device is an over-the-counter device intended for 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, in patients with Fitzpatrick Skin Phototypes I-V.

Source page: https://510kreport.com/device/K220248
Methodology: https://510kreport.com/methodology