# K031988: Aurora DS

- Pathway: 510(k) (Special)
- Applicant: Syneron Medical, Ltd.
- Decided: Aug 1, 2003 after 35 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: 8 generations back to K943450 (1995). 38 ancestors in all.
450 later devices descend from it; 2 cite it directly.
0 of 489 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021149: Aurora DS, Syneron Medical, Ltd. (2002)

## Most influential descendants
- K033586: Modification to Aurora DS (2003), 303 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K031988
Methodology: https://510kreport.com/methodology