510(k) Report

510(k) · Cleared

Cleared

Waterlase for Apicoectomy

K022803510(k) TraditionalCleared Feb 3, 2003164-day reviewClass II21 CFR 872.4120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biolase Technology, Inc. · MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation

Cleared on Feb 3, 2003 after a 164-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Feb 3, 2003
Review
164 days
Class
Class II
Product code
MXF
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 2 descendants cleared2009: 1 descendant cleared2006: 1 descendant cleared2015: 1 descendant cleared2007: 2 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK022803 Waterlase for ApicoectomyBiolase Technology, Inc. · 2003
  2. Descendant · cites it directly · 8 of its ownK030523 WaterlaseBiolase Technology, Inc. · 2004
  3. Descendant · 2 generations on · 5 of its ownK052354 Oculase MDBiolase Technology, Inc. · 2006
  4. Descendant · 3 generations on · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
  5. Descendant · 4 generations on · 1 of its ownK080530 Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008
  6. Descendant · 2 generations on · 1 of its ownK081589 Waterlase, Version 3.0Biolase Technology, Inc. · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12007: 22008: 22009: 12015: 12022: 1
2004high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K030523WaterlaseBiolase Technology, Inc. · 2004 · cites it directly8descendants
  • K052354Oculase MDBiolase Technology, Inc. · 2006 · 2 generations on5descendants
  • K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007 · 3 generations on2descendants
  • K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008 · 4 generations on1descendant
  • K081589Waterlase, Version 3.0Biolase Technology, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022803Waterlase for ApicoectomyBiolase Technology, Inc.2003—
+1K030523WaterlaseBiolase Technology, Inc.2004—
+2K052354Oculase MDBiolase Technology, Inc.2006—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.2007—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.2008—
+2K081589Waterlase, Version 3.0Biolase Technology, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200720
200820
200910
201510
202210
FIG. 1 — Lineage of K022803, 2003–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MXF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030523WaterlaseBiolase Technology, Inc.20048

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030523 (Biolase Technology, Inc., 2004) has gone furthest, with 8 descendants of its own.

How does its category compare?

All MXF devices

MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MXF

FDA has decided no MXF device since 2007.

Median 510(k) review, days · MXF

Too few MXF 510(k)s in any year since 2007 to give a median.

Recalls per year · MXF

No recall names MXF since 2007.

Adverse event reports per year · MXF

No MAUDE report names MXF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Biolase Technology, Inc.

31 FDA decisions under this applicant name. See the company

  • K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013
  • K130465EPIC 10SBiolase Technology, Inc. · 2013
  • K121327Diolase 10SBiolase Technology, Inc. · 2013
  • K121286EPIC 10Biolase Technology, Inc. · 2012
  • K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 20101 recall

Recent decisions in MXF

The MXF category page

  • K013908Waterlase MillenniumBiolase Technology, Inc. · 2002
  • K012511Waterlase MillenniumBiolase Technology, Inc. · 2002
  • K990908MillenniumEndo Technic Corp. · 1999
  • K990219Modification of MillenniumBiolase Technology, Inc. · 1999

https://510kreport.com/device/K022803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022803: Waterlase for Apicoectomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022803

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026