# K013201: Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR

- Pathway: 510(k) (Traditional)
- Applicant: Cardiofocus, Inc.
- Decided: Mar 18, 2002 after 174 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: 1 generation back to K001975 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites 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 1.

## Most influential descendants
- K040744: Atrilaze Soft Tissue Ablation System (2004), 5 descendants of its own
- 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

## Indications for use
The CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or non-contact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue.

Source page: https://510kreport.com/device/K013201
Methodology: https://510kreport.com/methodology