Sandstone Medical Technologies, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121162 | POLARIS Q-SWITCH RUBY SYSTEM | July 18, 2012 |
| K110897 | CORTEX CO2 / ER:YAG LASER SYSTEM | July 1, 2011 |
| K110502 | TRIPLEX ER. YAG / ND: YAG SYSTEM | April 27, 2011 |
| K110304 | APEX ER. YAG / IPL SYSTEM | April 8, 2011 |
| K100893 | CHEVEUX DIODE LASER SYSTEM | June 16, 2010 |
| K093793 | LS-40 CO2 LASER SYSTEM MODEL LS-40 | February 18, 2010 |
| K082407 | MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM | February 3, 2009 |
| K082101 | LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE | November 5, 2008 |
| K081219 | APOLLO MINI IPL SYSTEM | June 30, 2008 |
| K041011 | ULTRALIGHT II ND:YAG LASER SYSTEM | December 14, 2004 |
| K040563 | LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) | October 8, 2004 |