AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM— 510(k) K062248
Substantially EquivalentNorth American Clinical Lasers, Ltd.
FDA 510(k) clearance K062248 for AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM, Substantially Equivalent on 2006-08-17. Applicant: North American Clinical Lasers, Ltd..
Clearance details
- Applicant
- North American Clinical Lasers, Ltd.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.