Sandstone Medical Technologies, LLC
Woodland, CA, US
Sandstone Medical Technologies, LLC appears in FDA device records in Woodland, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Sandstone Medical Technologies, LLC between 2004 and 2012. The busiest year on record is 2011, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121162 | POLARIS Q-SWITCH RUBY SYSTEM | GEX | Substantially Equivalent | |
| K110897 | CORTEX CO2 / ER:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K110502 | TRIPLEX ER. YAG / ND: YAG SYSTEM | GEX | Substantially Equivalent | |
| K110304 | APEX ER. YAG / IPL SYSTEM | GEX | Substantially Equivalent | |
| K100893 | CHEVEUX DIODE LASER SYSTEM | GEX | Substantially Equivalent | |
| K093793 | LS-40 CO2 LASER SYSTEM MODEL LS-40 | GEX | Substantially Equivalent | |
| K082407 | MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K082101 | LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE | GEX | Substantially Equivalent | |
| K081219 | APOLLO MINI IPL SYSTEM | GEX | Substantially Equivalent | |
| K041011 | ULTRALIGHT II ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K040563 | LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain