# K120080: Shaser HRS2 Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Shaser, Inc.
- Decided: May 25, 2012 after 135 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 12 generations back to K950019 (1995). 42 ancestors in all.
135 later devices descend from it; 3 cite it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103560: Shaser Ipl Hair Removal System, Shaser, Inc. (2011) Summary page 1.
- K103184: Silk'n Flash N GO, Home Skinovations, Ltd. (2010) Summary page 1.

## Most influential descendants
- K131649: ME (2013), 125 descendants of its own
- 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
- K132266: Shaser HRS2 RX Hair Removal System (2013), 97 descendants of its own

## Indications for use
The SHASER HRS2 Hair Removal System is an over-the-counter device intended for removal of unwanted hair. 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/K120080
Methodology: https://510kreport.com/methodology