# K130315: Ipulse Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Cyden Limited
- Decided: Jul 12, 2013 after 154 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: 13 generations back to K950019 (1995). 30 ancestors in all.
124 later devices descend from it; 7 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122280: Ipulse Smoothskin Hair Removal System, Cyden Limited (2012) Summary page 1.
- K103560: Shaser Ipl Hair Removal System, Shaser, Inc. (2011) Summary page 1.
- K082298: Flash N' GO, Home Skinovations, Ltd. (2008) Summary page 1.

## Most influential descendants
- K143003: iPulse Smooth Skin Gold Hair Removal System (2015), 123 descendants of its own
- K160968: iPulse SmoothSkin Gold Hair Removal Device (2016), 117 descendants of its own
- K161428: PerfectSmooth (2017), 115 descendants of its own
- 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

## Indications for use
The Pulse Hair Removal System is an over-the-counter device intended for removal of unwanted hair.

Source page: https://510kreport.com/device/K130315
Methodology: https://510kreport.com/methodology