# K082409: Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083

- Pathway: 510(k) (Traditional)
- Applicant: Endophotonix, Inc.
- Decided: Jan 21, 2009 after 153 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: 6 generations back to K980668 (1998). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061489: Atrilaze MI Surgical Ablation System, Medical Cv, Inc. (2007) Summary page 2.
- K081457: Atrilaze Laser Ablation System, Medical Cv, Inc. (2008) Summary page 2.

## Indications for use
The SOLAR TM Surgical Ablation System is indicated for delivery of 810nm, 1064nm, or 1083nm laser light to soft tissue, under visualization, during surgical procedures Indications include the ablation, or coagulation of soft tissue Warning: The SOLAR TM Surgical Ablation System is not indicated fOr the treatment of cardiac arrhythmias The risk of actual damage to adjacent organs from the instrument exists and perforation, rupture or tearing of tissue, may occur as a complication of laser use Burns can occur if the laser energy is not correctly applied These complications may be serious

Source page: https://510kreport.com/device/K082409
Methodology: https://510kreport.com/methodology