FDA 510(k) Applications Submitted by BIOLASE TECHNOLOGY, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990219 |
01/22/1999 |
MODIFICATION OF MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
| K980585 |
02/17/1998 |
MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
| K130465 |
02/25/2013 |
EPIC 10S |
BIOLASE TECHNOLOGY, INC. |
| K122368 |
08/06/2012 |
WATERLASE IPLUS ALL TISSUE LASER |
BIOLASE TECHNOLOGY, INC. |
| K090181 |
01/26/2009 |
WATERLASE MD |
BIOLASE TECHNOLOGY, INC. |
| K081589 |
06/05/2008 |
WATERLASE, VERSION 3.0 |
BIOLASE TECHNOLOGY, INC. |
| K101658 |
06/11/2010 |
WATERLASE MD TURBO PLUS MODEL 7200XXX |
BIOLASE TECHNOLOGY, INC. |
| K091746 |
06/16/2009 |
WATERLASE MD, MODEL 7100102 |
BIOLASE TECHNOLOGY, INC. |
| K071734 |
06/26/2007 |
WATERLASE MD DERM |
BIOLASE TECHNOLOGY, INC. |
| K091922 |
06/30/2009 |
WATERLASE C100, MODEL 7100104 |
BIOLASE TECHNOLOGY, INC. |
| K082938 |
10/02/2008 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
| K083069 |
10/15/2008 |
EZLASE 10W |
BIOLASE TECHNOLOGY, INC. |
| K093852 |
12/16/2009 |
EZLASE 3 LASER SYSTEM |
BIOLASE TECHNOLOGY, INC. |
| K071363 |
05/15/2007 |
WATERLASE AND WATERLASE MD |
BIOLASE TECHNOLOGY, INC. |
| K083595 |
12/05/2008 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
| K000290 |
01/31/2000 |
LAZERSMILE, LAZERWHITE |
BIOLASE TECHNOLOGY, INC. |
| K030523 |
02/19/2003 |
WATERLASE |
BIOLASE TECHNOLOGY, INC. |
| K030539 |
02/20/2003 |
LASERSMILE |
BIOLASE TECHNOLOGY, INC. |
| K011041 |
04/05/2001 |
WATERLASE, MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
| K031140 |
04/10/2003 |
WATERLASE |
BIOLASE TECHNOLOGY, INC. |
| K991994 |
06/14/1999 |
TWILIGHT |
BIOLASE TECHNOLOGY, INC. |
| K061898 |
07/03/2006 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
| K012511 |
08/06/2001 |
WATERLASE MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
| K022803 |
08/23/2002 |
WATERLASE FOR APICOECTOMY |
BIOLASE TECHNOLOGY, INC. |
| K003385 |
10/31/2000 |
TWILITE, TWILITE WHITE |
BIOLASE TECHNOLOGY, INC. |
| K013908 |
11/26/2001 |
WATERLASE MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
| K083927 |
12/31/2008 |
WATERLASE MD |
BIOLASE TECHNOLOGY, INC. |
| K052354 |
08/29/2005 |
OCULASE MD |
BIOLASE TECHNOLOGY, INC. |
| K121286 |
04/30/2012 |
EPIC 10 |
BIOLASE TECHNOLOGY, INC. |
| K121327 |
05/02/2012 |
DIOLASE 10S |
BIOLASE TECHNOLOGY, INC. |
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