# K131649: ME

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Beauty, Ltd.
- Decided: Dec 11, 2013 after 189 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: 14 generations back to K950019 (1995). 46 ancestors in all.
125 later devices descend from it; 2 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123845: ME, Syneron Beauty, Ltd. (2013) Summary page 1.
- K121598: ME HAIR2GO, Syneron Medical, Ltd. (2012) Summary page 2.
- K120080: Shaser HRS2 Hair Removal System, Shaser, Inc. (2012) Summary page 1.
- K103560: Shaser Ipl Hair Removal System, Shaser, Inc. (2011) Summary page 1.
- K090820: Tria Hair Removal Laser System, Spectragenics, Inc. (2009) Summary page 1.
- K120737: Tria Laser Hair Removal System, Tria Beauty, Inc. (2012) 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 me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

Source page: https://510kreport.com/device/K131649
Methodology: https://510kreport.com/methodology