# K021149: Aurora DS

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Jul 9, 2002 after 90 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: 7 generations back to K943450 (1995). 37 ancestors in all.
750 later devices descend from it; 3 cite it directly.
0 of 788 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1.
- K954031: Compu-Blend Epilator, R. A. Fischer Co. Corp. (1996) Summary page 1.
- K000944: Thermage Thermacool System, Thermage, Inc. (2000) Summary page 1.

## Most influential descendants
- K024064: Polaris DS (2003), 681 descendants of its own
- K030186: Polris LV (2003), 680 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K052324: Polaris LV, Lva Applicator (2005), 456 descendants of its own

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

Source page: https://510kreport.com/device/K021149
Methodology: https://510kreport.com/methodology