Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biolase Technology, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
275 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | Biolase Technology, Inc. | 2013-05-02 | 269 | 0 |
| K130465 | EPIC 10S | Biolase Technology, Inc. | 2013-04-11 | 45 | 0 |
| K121327 | DIOLASE 10S | Biolase Technology, Inc. | 2013-02-01 | 275 | 0 |
| K121286 | EPIC 10 | Biolase Technology, Inc. | 2012-09-28 | 151 | 0 |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | Biolase Technology, Inc. | 2010-08-11 | 61 | 1 |
| K093852 | EZLASE 3 LASER SYSTEM | Biolase Technology, Inc. | 2010-03-12 | 86 | 0 |
| K091746 | WATERLASE MD, MODEL 7100102 | Biolase Technology, Inc. | 2009-12-07 | 174 | 0 |
| K083927 | WATERLASE MD | Biolase Technology, Inc. | 2009-10-01 | 274 | 0 |
| K091922 | WATERLASE C100, MODEL 7100104 | Biolase Technology, Inc. | 2009-07-14 | 14 | 0 |
| K083595 | EZLASE | Biolase Technology, Inc. | 2009-04-14 | 130 | 0 |
| K090181 | WATERLASE MD | Biolase Technology, Inc. | 2009-02-11 | 16 | 0 |
| K082938 | EZLASE | Biolase Technology, Inc. | 2008-12-22 | 81 | 0 |
| K083069 | EZLASE 10W | Biolase Technology, Inc. | 2008-11-13 | 29 | 0 |
| K081589 | WATERLASE, VERSION 3.0 | Biolase Technology, Inc. | 2008-06-13 | 8 | 0 |
| K071363 | WATERLASE AND WATERLASE MD | Biolase Technology, Inc. | 2008-02-12 | 273 | 0 |
| K071734 | WATERLASE MD DERM | Biolase Technology, Inc. | 2008-01-25 | 213 | 0 |
| K061898 | EZLASE | Biolase Technology, Inc. | 2007-01-26 | 207 | 0 |
| K052354 | OCULASE MD | Biolase Technology, Inc. | 2006-07-05 | 310 | 0 |
| K031140 | WATERLASE | Biolase Technology, Inc. | 2004-07-07 | 454 | 1 |
| K030523 | WATERLASE | Biolase Technology, Inc. | 2004-01-30 | 345 | 0 |
| K030539 | LASERSMILE | Biolase Technology, Inc. | 2003-10-10 | 232 | 0 |
| K022803 | WATERLASE FOR APICOECTOMY | Biolase Technology, Inc. | 2003-02-03 | 164 | 0 |
| K013908 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | 2002-02-12 | 78 | 0 |
| K012511 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | 2002-01-18 | 165 | 0 |
| K011041 | WATERLASE, MILLENNIUM | Biolase Technology, Inc. | 2001-07-03 | 89 | 0 |
| K003385 | TWILITE, TWILITE WHITE | Biolase Technology, Inc. | 2001-01-25 | 86 | 0 |
| K000290 | LAZERSMILE, LAZERWHITE | Biolase Technology, Inc. | 2000-04-14 | 74 | 0 |
| K991994 | TWILIGHT | Biolase Technology, Inc. | 1999-09-10 | 88 | 0 |
| K990219 | MODIFICATION OF MILLENNIUM | Biolase Technology, Inc. | 1999-02-24 | 33 | 0 |
| K980585 | MILLENNIUM | Biolase Technology, Inc. | 1998-10-08 | 233 | 0 |
| K950248 | LASERSPRAY(TM) | Biolase Technology, Inc. | 1995-02-24 | 35 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda