# K181568: IPL Salon Hair Reduction System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
- Decided: Sep 11, 2018 after 89 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: 18 generations back to K950019 (1995). 56 ancestors in all.
88 later devices descend from it; 9 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161428: PerfectSmooth, Shen Zhen Cosbeauty Co., Ltd. (2017) Summary page 5.
- K140631: Lumena FH Hair Removal System, Shaser, Inc. (2014) Summary page 5.

## Most influential descendants
- K192432: IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 (2019), 66 descendants of its own
- K212318: IPL Hair Removal (2022), 26 descendants of its own
- K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C (2022), 25 descendants of its own
- K210311: Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. (2021), 24 descendants of its own
- K212314: IPL Hair Removal Device (2021), 23 descendants of its own

## Indications for use
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Source page: https://510kreport.com/device/K181568
Methodology: https://510kreport.com/methodology