LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE— 510(k) K082101
Substantially EquivalentSandstone Medical Technologies, LLC
FDA 510(k) clearance K082101 for LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE, Substantially Equivalent on 2008-11-05. Applicant: Sandstone Medical Technologies, LLC.
Clearance details
- Applicant
- Sandstone Medical Technologies, LLC
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, 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.