# K213020: IPL hair removal machine

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Borria Technology Co., Ltd.
- Decided: Dec 16, 2021 after 87 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.
No later device cites it as a predicate yet.
0 of 61 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.

## Indications for use
IPL hair removal machine 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.

Source page: https://510kreport.com/device/K213020
Methodology: https://510kreport.com/methodology