510(k) · Cleared
ClearedWaterlase and Waterlase MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 12, 2008 as substantially equivalent to K053167 (Dentsply Intl., Inc., 2005) and 1 other predicate after a 273-day review. Its family tree reaches back 3 generations to 2001. 28 later devices descend from it.
- Decided
- Feb 12, 2008
- Review
- 273 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003422 (2001). 28 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 2 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 1 generation backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- This deviceK071363 Waterlase and Waterlase MDBiolase Technology, Inc. · 2008
- Descendant · cites it directly · 26 of its ownK090181 Waterlase MDBiolase Technology, Inc. · 2009
- Descendant · cites it directly · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016
- Descendant · 2 generations on · 19 of its ownK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
- Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K090181Waterlase MDBiolase Technology, Inc. · 2009 · cites it directly26descendants
- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · cites it directly25descendants
- K161669Waterlase ExpressBiolase, Inc. · 2016 · 2 generations on21descendants
- K190319Waterlase Laser System FamilyBiolase, Inc. · 2019 · 2 generations on19descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −2 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −1 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| 0 (this device) | K071363 | Waterlase and Waterlase MD | Biolase Technology, Inc. | 2008 | — |
| +1 | K090181 | Waterlase MD | Biolase Technology, Inc. | 2009 | — |
| +1 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| +2 | K161669 | Waterlase Express | Biolase, Inc. | 2016 | — |
| +2 | K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K053167 | Biopure Mtad Root Canal CleanserSummary page 2…root canal disinfection requested with this submission, the Waterlase®, and Waterlase®MD are equivalent to the following products: BIOPURE MTAD Root Canal Cleanser K053 167, and EndoPure Root Canal Cleanser K032361. Comparison between Waterlase®, and Waterlase®MD and the predicate devices is inc… | 2005 |
| * | K032361 | Endopure Root Canal CleanserSummary page 2…bmission, the Waterlase®, and Waterlase®MD are equivalent to the following products: BIOPURE MTAD Root Canal Cleanser K053 167, and EndoPure Root Canal Cleanser K032361. Comparison between Waterlase®, and Waterlase®MD and the predicate devices is included in Table 1. Based on the comparison, th… | 2004 |
| * | — | Waterlase® Named without a submission number |
What descends from it? (28)
See all 283 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090181 (Biolase Technology, Inc., 2009) has gone furthest, with 26 descendants of its own.
- 8 other devices also cite its predicate K053167.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
Root Canal Disinfection
Laser root canal disinfection after endodontic instrumentation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071363: Waterlase and Waterlase MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071363
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026