510(k) · Cleared
ClearedWaterlase Millennium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Cleared on Feb 12, 2002 after a 78-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Feb 12, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- MXF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK013908 Waterlase MillenniumBiolase Technology, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK030523 WaterlaseBiolase Technology, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK052354 Oculase MDBiolase Technology, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
- Descendant · 4 generations on · 1 of its ownK080530 Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013908 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| +1 | K030523 | Waterlase | Biolase Technology, Inc. | 2004 | — |
| +2 | K052354 | Oculase MD | Biolase Technology, Inc. | 2006 | — |
| +3 | K063867 | Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2007 | — |
| +4 | K080530 | Modification to Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2008 | — |
| +2 | K081589 | Waterlase, Version 3.0 | Biolase Technology, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Dental handpiece - Dentsply Named without a submission number | |
| * | — | Dental handpiece Star Dental Named without a submission number | |
| * | — | Dental handpiece Siemens Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030523 | Waterlase | 2004 | 8 |
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 devicesMXF 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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Class I, II, III, IV and V cavity preparation.
Caries removal,
Hard tissue surface roughening or etching.
Enameloplasty, excavation of pits and fissures for placement of sealants.
Cutting, shaving, contouring and resection of oral osseous tissues (bone).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013908: Waterlase Millennium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013908
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026