# K041969: Aurora DS

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Oct 19, 2004 after 89 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: 10 generations back to K943450 (1995). 109 ancestors in all.
302 later devices descend from it; 2 cite it directly.
0 of 412 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033586: Modification to Aurora DS, Syneron Medical, Ltd. (2003) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K033946: Lovely System, Msq (M2), Ltd. (2004) Summary page 1.

## Most influential descendants
- 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
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own

## Indications for use
The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.

Source page: https://510kreport.com/device/K041969
Methodology: https://510kreport.com/methodology