# K040744: Atrilaze Soft Tissue Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Cv, Inc.
- Decided: Nov 30, 2004 after 252 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: 2 generations back to K001975 (2000). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001975: Ceralas D10 810NM Laser, Model Ceralas D10-60, Ceram Optec, Inc. (2000) Summary page 2.
- K013201: Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR, Cardiofocus, Inc. (2002) Summary page 2.

## Most influential descendants
- K052495: Atrilaze Malleable Ablation Probe (2005), 4 descendants of its own
- 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. AtrilazeTM Soft Tissue Ablation System is indicated for delivery of 81Onm 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.

Source page: https://510kreport.com/device/K040744
Methodology: https://510kreport.com/methodology