# K062248: Azuryt Model CTL 1401, CO2 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: North American Clinical Lasers, Ltd.
- Decided: Aug 17, 2006 after 14 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: 3 generations back to K953074 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042439: Azuryt Model CLT 1401, CO2 Surgical Laser System, Diamond Age Systems, Inc. (2004) Summary page 1.

## Indications for use
The Azuryt Model CTL 1401, CO 2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.

Source page: https://510kreport.com/device/K062248
Methodology: https://510kreport.com/methodology