# K131712: A-Tone Ipl System

- Pathway: 510(k) (Traditional)
- Applicant: Ybk Investment, Inc.
- Decided: May 30, 2014 after 353 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 K910422 (1992). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 2.
- K122995: Intense Pulsed Light (Ipl) Systems, Beijing Kes Biology Technology Co., Ltd. (2013) Summary page 2.

## Indications for use
A-tone systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K131712
Methodology: https://510kreport.com/methodology