# K031671: Polaris WR

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Dec 1, 2003 after 186 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: 11 generations back to K943450 (1995). 81 ancestors in all.
678 later devices descend from it; 8 cite it directly.
0 of 760 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030186: Polris LV, Syneron Medical, Ltd. (2003) Summary page 1.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K030142: Thermacool TC System, Thermage, Inc. (2003) Summary page 1.

## Most influential descendants
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K041959: Polaris DS/Comet (2004), 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
- K060448: Lumenis One Family of Systems; Lumenis One. (2006), 297 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own

## Indications for use
The Polaris WR is indicated for non invasive wrinkles treatment.

Source page: https://510kreport.com/device/K031671
Methodology: https://510kreport.com/methodology