# K052324: Polaris LV, Lva Applicator

- Pathway: 510(k) (Special)
- Applicant: Syneron Medical, Ltd.
- Decided: Sep 14, 2005 after 20 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). 62 ancestors in all.
456 later devices descend from it; 3 cite it directly.
0 of 519 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.

## 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
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 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 Polaris LV is intended for use in dermatology for treatment of vascular lesions.

Source page: https://510kreport.com/device/K052324
Methodology: https://510kreport.com/methodology