# K221643: Hair Removal Device (Model: IPL-D26, IPL-D19)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Desida Technology Co., Ltd.
- Decided: Oct 21, 2022 after 137 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: 17 generations back to K950019 (1995). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 5.

## Indications for use
The Hair Removal Devices (models [PL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Source page: https://510kreport.com/device/K221643
Methodology: https://510kreport.com/methodology