# K033586: Modification to Aurora DS

- Pathway: 510(k) (Special)
- Applicant: Syneron Medical, Ltd.
- Decided: Dec 10, 2003 after 27 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 9 generations back to K943450 (1995). 39 ancestors in all.
303 later devices descend from it; 1 cites it directly.
0 of 343 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031988: Aurora DS, Syneron Medical, Ltd. (2003) Summary page 1.

## Most influential descendants
- K041969: Aurora DS (2004), 302 descendants of its own
- K050796: Aurora DS, DS Applicator (2005), 301 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own

## Indications for use
The Aurora DS is indicated for non-invasive hair removal.

Source page: https://510kreport.com/device/K033586
Methodology: https://510kreport.com/methodology