Biolase Technology, Inc.
Medical device manufacturer in Irvine, CA.
31510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K122368 | Waterlase Iplus All Tissue LaserGEX · Traditional | 05/02/2013SE |
| K130465 | Epic 10SGEX · Traditional | 04/11/2013SE |
| K121327 | Diolase 10SGEX · Traditional | 02/01/2013SE |
| K121286 | Epic 10GEX · Special | 09/28/2012SE |
| K101658 | Waterlase MD Turbo Plus Model 7200XXXGEX · Traditional | 08/11/2010SE |
| K093852 | Ezlase 3 Laser SystemGEX · Traditional | 03/12/2010SE |
| K091746 | Waterlase MD, Model 7100102GEX · Traditional | 12/07/2009SE |
| K083927 | Waterlase MDGEX · Traditional | 10/01/2009SE |
| K091922 | Waterlase C100, Model 7100104GEX · Special | 07/14/2009SE |
| K083595 | EzlaseILY · Traditional | 04/14/2009SE |
| K090181 | Waterlase MDGEX · Special | 02/11/2009SE |
| K082938 | EzlaseGEX · Traditional | 12/22/2008SE |
| K083069 | Ezlase 10WGEX · Special | 11/13/2008SE |
| K081589 | Waterlase, Version 3.0GEX · Special | 06/13/2008SE |
| K071363 | Waterlase and Waterlase MDGEX · Traditional | 02/12/2008SE |
| K071734 | Waterlase MD DermGEX · Traditional | 01/25/2008SE |
| K061898 | EzlaseGEX · Traditional | 01/26/2007SE |
| K052354 | Oculase MDGEX · Traditional | 07/05/2006SE |
| K031140 | WaterlaseGEX · Traditional | 07/07/2004SE |
| K030523 | WaterlaseGEX · Traditional | 01/30/2004SE |
| K030539 | LasersmileGEX · Traditional | 10/10/2003SE |
| K022803 | Waterlase for ApicoectomyMXF · Traditional | 02/03/2003SE |
| K013908 | Waterlase MillenniumMXF · Traditional | 02/12/2002SE |
| K012511 | Waterlase MillenniumMXF · Traditional | 01/18/2002SE |
| K011041 | Waterlase, MillenniumGEX · Traditional | 07/03/2001SE |
| K003385 | Twilite, Twilite WhiteGEX · Traditional | 01/25/2001SE |
| K000290 | Lazersmile, LazerwhiteEFW · Traditional | 04/14/2000SE |
| K991994 | TwilightGEX · Traditional | 09/10/1999SE |
| K990219 | Modification of MillenniumMXF · Traditional | 02/24/1999SE |
| K980585 | MillenniumEFB · Traditional | 10/08/1998SE |
| K950248 | Laserspray(Tm)GEX · Traditional | 02/24/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2263-2014 Class II | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No.…Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user… | 06/12/2014Terminated |