# K101901: Ipl Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Starlight Science & Technology Development
- Decided: Mar 8, 2011 after 243 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). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C, Shenzhen Gsd Tech Co., Ltd. (2009) Summary page 1.
- K083915: Angelite Family of Intense Pulsed Light Systems, Models Angelite-DDC and Angelite-SDC, Advanced Technology Laser Co., Ltd. (2009)

## Indications for use
The IPL Therapy Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.

Source page: https://510kreport.com/device/K101901
Methodology: https://510kreport.com/methodology