# K123845: ME

- Pathway: 510(k) (Special)
- Applicant: Syneron Beauty, Ltd.
- Decided: Jan 10, 2013 after 28 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: 13 generations back to K950019 (1995). 43 ancestors in all.
126 later devices descend from it; 1 cites it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121598: ME HAIR2GO, Syneron Medical, Ltd. (2012) 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
- K181568: IPL Salon Hair Reduction System (2018), 88 descendants of its own

## Indications for use
The me is an over-the-counter device intended for the removal of unwanted hair.

Source page: https://510kreport.com/device/K123845
Methodology: https://510kreport.com/methodology