# K061489: Atrilaze MI Surgical Ablation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medical Cv, Inc.
- Decided: Mar 16, 2007 after 289 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: 5 generations back to K980668 (1998). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 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.
- K060680: Atrilaze Surgical Ablation System, Medical Cv, Inc. (2006) Summary page 2.
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 2.
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System, Afx, Inc. (2002) Summary page 2.

## Most influential descendants
- 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 SOLAR™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue, under direct visualization, during surgical procedures. Indications include the ablation, or coagulation of soft tissue.

Source page: https://510kreport.com/device/K061489
Methodology: https://510kreport.com/methodology