# K041959: Polaris DS/Comet

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Nov 8, 2004 after 110 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: 12 generations back to K943450 (1995). 85 ancestors in all.
301 later devices descend from it; 2 cite it directly.
0 of 387 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024064: Polaris DS, Syneron Medical, Ltd. (2003) Summary page 1.
- K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 1.
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 1.
- K030805: Mythos 500, Msq (M2), Ltd. (2003) Summary page 1.

## Most influential descendants
- 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
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
The Polaris DS / Comet is indicated for hair removal, permanent hair reduction. The Polaris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.

Source page: https://510kreport.com/device/K041959
Methodology: https://510kreport.com/methodology