# K210119: IPL Hair Removal Device (Model: KCA423)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.
- Decided: May 21, 2021 after 122 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IPL Hair Removal Device (Model: KCA423) indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. 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/K210119
Methodology: https://510kreport.com/methodology