Biolase Technology Inc
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 31
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2263-2014 | Class II | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. | June 12, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | May 2, 2013 |
| K130465 | EPIC 10S | April 11, 2013 |
| K121327 | DIOLASE 10S | February 1, 2013 |
| K121286 | EPIC 10 | September 28, 2012 |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | August 11, 2010 |
| K093852 | EZLASE 3 LASER SYSTEM | March 12, 2010 |
| K091746 | WATERLASE MD, MODEL 7100102 | December 7, 2009 |
| K083927 | WATERLASE MD | October 1, 2009 |
| K091922 | WATERLASE C100, MODEL 7100104 | July 14, 2009 |
| K083595 | EZLASE | April 14, 2009 |
| K090181 | WATERLASE MD | February 11, 2009 |
| K082938 | EZLASE | December 22, 2008 |
| K083069 | EZLASE 10W | November 13, 2008 |
| K081589 | WATERLASE, VERSION 3.0 | June 13, 2008 |
| K071363 | WATERLASE AND WATERLASE MD | February 12, 2008 |
| K071734 | WATERLASE MD DERM | January 25, 2008 |
| K061898 | EZLASE | January 26, 2007 |
| K052354 | OCULASE MD | July 5, 2006 |
| K031140 | WATERLASE | July 7, 2004 |
| K030523 | WATERLASE | January 30, 2004 |