# K052495: Atrilaze Malleable Ablation Probe

- Pathway: 510(k) (Special)
- Applicant: Medical Cv, Inc.
- Decided: Oct 11, 2005 after 29 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: 3 generations back to K980668 (1998). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040744: Atrilaze Soft Tissue Ablation System, Medical Cv, Inc. (2004) Summary page 2.
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM), Cardiofocus, Inc. (2001)

## Most influential descendants
- K060680: Atrilaze Surgical Ablation System (2006), 3 descendants of its own
- K081457: Atrilaze Laser Ablation System (2008), 1 descendant of its own
- K061489: Atrilaze MI Surgical Ablation System (2007), 1 descendant of its own
- 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 (2009), 0 descendants of its own

## Indications for use
The MedicalCV, Inc. Atrilaze Surgical Ablation System is indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue. Warning: The Atrilaze 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/K052495
Methodology: https://510kreport.com/methodology