# K230473: IPL Hair Removal Device Models: MLY-T069

- Pathway: 510(k) (Traditional)
- Applicant: Miley Technology (Hebei) Co., Ltd.
- Decided: Jun 15, 2023 after 113 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 is an over-the-counter device used to remove excess hairs for adults, suitable for home or medical institution use. The device is used for adults with Fitzpatrick skin types [-IV.

Source page: https://510kreport.com/device/K230473
Methodology: https://510kreport.com/methodology