# K223524: IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03

- Pathway: 510(k) (Traditional)
- Applicant: Morlaser Shenzhen Co., Ltd.
- Decided: Feb 16, 2023 after 85 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). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213041: IPL Hair Removal, Model: OBT-02, Glan Electronics Co., Ltd. (2021) Summary page 4.
- K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C, Shenzhen Ulike Smart Electronics Co., Ltd. (2022) Summary page 4.

## Indications for use
The IPL Hair Removal is an over-the-counter device intended for 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.

Source page: https://510kreport.com/device/K223524
Methodology: https://510kreport.com/methodology