# K220927: IPL Hair Removal

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Qiaochengli Technology Co., Ltd.
- Decided: Jun 2, 2022 after 63 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
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: TFDA06S-A) is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

Source page: https://510kreport.com/device/K220927
Methodology: https://510kreport.com/methodology