# K161428: PerfectSmooth

- Pathway: 510(k) (Traditional)
- Applicant: Shen Zhen Cosbeauty Co., Ltd.
- Decided: Mar 23, 2017 after 304 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: 17 generations back to K950019 (1995). 51 ancestors in all.
115 later devices descend from it; 10 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 4.

## Most influential descendants
- K181568: IPL Salon Hair Reduction System (2018), 88 descendants of its own
- 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
- K173813: IPL Hair Removal Device Joy Version (2018), 36 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

## Indications for use
The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

Source page: https://510kreport.com/device/K161428
Methodology: https://510kreport.com/methodology