# K081457: Atrilaze Laser Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Cv, Inc.
- Decided: Aug 8, 2008 after 77 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). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060680: Atrilaze Surgical Ablation System, Medical Cv, Inc. (2006) 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 ATRILAZE Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm 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. The ATRILAZE Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

Source page: https://510kreport.com/device/K081457
Methodology: https://510kreport.com/methodology