# K030186: Polris LV

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Apr 14, 2003 after 83 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: 9 generations back to K943450 (1995). 61 ancestors in all.
680 later devices descend from it; 4 cite it directly.
0 of 742 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). Cleared while this submission was under review Summary page 1.
- K980537: ND: Yag Accessory for Photoderm System, Esc Medical Systems, Ltd. (1998) Summary page 1.
- K013028: Palomar SLP 1000, Palomar Medical Products, Inc. (2001)
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System, Dornier Medtech America, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Polaris LV is indicated for treatment of vascular lesions.

Source page: https://510kreport.com/device/K030186
Methodology: https://510kreport.com/methodology