Company ยท US
Biolase Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2013. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2013 | K122368 | WATERLASE IPLUS ALL TISSUE LASER Biolase Technology, Inc. | GEX |
| Apr 11, 2013 | K130465 | EPIC 10S Biolase Technology, Inc. | GEX |
| Feb 1, 2013 | K121327 | DIOLASE 10S Biolase Technology, Inc. | GEX |
| Sep 28, 2012 | K121286 | EPIC 10 Biolase Technology, Inc. | GEX |
| Aug 11, 2010 | K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX Biolase Technology, Inc. | GEX |
| Mar 12, 2010 | K093852 | EZLASE 3 LASER SYSTEM Biolase Technology, Inc. | GEX |
| Dec 7, 2009 | K091746 | WATERLASE MD, MODEL 7100102 Biolase Technology, Inc. | GEX |
| Oct 1, 2009 | K083927 | WATERLASE MD Biolase Technology, Inc. | GEX |
| Jul 14, 2009 | K091922 | WATERLASE C100, MODEL 7100104 Biolase Technology, Inc. | GEX |
| Apr 14, 2009 | K083595 | EZLASE Biolase Technology, Inc. | ILY |
| Feb 11, 2009 | K090181 | WATERLASE MD Biolase Technology, Inc. | GEX |
| Dec 22, 2008 | K082938 | EZLASE Biolase Technology, Inc. | GEX |
| Nov 13, 2008 | K083069 | EZLASE 10W Biolase Technology, Inc. | GEX |
| Jun 13, 2008 | K081589 | WATERLASE, VERSION 3.0 Biolase Technology, Inc. | GEX |
| Feb 12, 2008 | K071363 | WATERLASE AND WATERLASE MD Biolase Technology, Inc. | GEX |
| Jan 25, 2008 | K071734 | WATERLASE MD DERM Biolase Technology, Inc. | GEX |
| Jan 26, 2007 | K061898 | EZLASE Biolase Technology, Inc. | GEX |
| Jul 5, 2006 | K052354 | OCULASE MD Biolase Technology, Inc. | GEX |
| Jul 7, 2004 | K031140 | WATERLASE Biolase Technology, Inc. | GEX |
| Jan 30, 2004 | K030523 | WATERLASE Biolase Technology, Inc. | GEX |
| Oct 10, 2003 | K030539 | LASERSMILE Biolase Technology, Inc. | GEX |
| Feb 3, 2003 | K022803 | WATERLASE FOR APICOECTOMY Biolase Technology, Inc. | MXF |
| Feb 12, 2002 | K013908 | WATERLASE MILLENNIUM Biolase Technology, Inc. | MXF |
| Jan 18, 2002 | K012511 | WATERLASE MILLENNIUM Biolase Technology, Inc. | MXF |
| Jul 3, 2001 | K011041 | WATERLASE, MILLENNIUM Biolase Technology, Inc. | GEX |
| Jan 25, 2001 | K003385 | TWILITE, TWILITE WHITE Biolase Technology, Inc. | GEX |
| Apr 14, 2000 | K000290 | LAZERSMILE, LAZERWHITE Biolase Technology, Inc. | EFW |
| Sep 10, 1999 | K991994 | TWILIGHT Biolase Technology, Inc. | GEX |
| Feb 24, 1999 | K990219 | MODIFICATION OF MILLENNIUM Biolase Technology, Inc. | MXF |
| Oct 8, 1998 | K980585 | MILLENNIUM Biolase Technology, Inc. | EFB |
| Feb 24, 1995 | K950248 | LASERSPRAY(TM) Biolase Technology, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2014 | Biolase Technology Inc WaterLase iPlus Dental Laser System, Part No. 7200854-XX
Software Upgrade Kit, Part No. 6201463. Terminated |
GEX | K101658 |
| Feb 15, 2005 | Biolase Technology Inc Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive. Terminated |
LYB | K031140 |