# K060680: Atrilaze Surgical Ablation System

- Pathway: 510(k) (Special)
- Applicant: Medical Cv, Inc.
- Decided: Apr 11, 2006 after 27 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: 4 generations back to K980668 (1998). 8 ancestors in all.
3 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.
- K052495: Atrilaze Malleable Ablation Probe, Medical Cv, Inc. (2005) Summary page 2.

## Most influential descendants
- 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 Medical CV AtrilazeTM Surgical Ablation System is indicated for delivery of 810nm or 1064nm 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/K060680
Methodology: https://510kreport.com/methodology