# K143339: Mini me

- Pathway: 510(k) (Special)
- Applicant: Iluminage Ltd.(Formerly Syneron Beauty Ltd.)
- Decided: Dec 19, 2014 after 29 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: 15 generations back to K950019 (1995). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131649: ME, Syneron Beauty, Ltd. (2013) Summary page 4.

## Indications for use
The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini 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/K143339
Methodology: https://510kreport.com/methodology
