510(k) · Cleared
ClearedTwinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumen Development and Manufacturing, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 18, 2007 after a 56-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
- Dec 18, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK072995 Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980…Lumen Development and Manufacturing, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK100474 Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980…Quicklase Limited · 2010
- Descendant · 2 generations on · 7 of its ownK152032 ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK193486 Epic 980Biolase, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK192617 Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020
- Descendant · 3 generations on · 1 of its ownK234085 LUNE™ PureHygieneEnamel Pure · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited · 2010 · cites it directly8descendants
- K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015 · 2 generations on7descendants
- K193486Epic 980Biolase, Inc. · 2020 · 2 generations on2descendants
- K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020 · 3 generations on2descendants
- K234085LUNE™ PureHygieneEnamel Pure · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072995 | Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser | Lumen Development and Manufacturing, Inc. | 2007 | — |
| +1 | K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model… | Quicklase Limited | 2010 | — |
| +2 | K152032 | ELUMI 810 + 980 Soft Tissue Laser | Azena Medical, LLC | 2015 | — |
| +2 | K193486 | Epic 980 | Biolase, Inc. | 2020 | — |
| +3 | K192617 | Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC | 2020 | — |
| +3 | K234085 | LUNE™ PureHygiene | Enamel Pure | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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 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?
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.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W | 2010 | 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, K100474 (Quicklase Limited, 2010) has gone furthest, with 8 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 | — |
https://510kreport.com/device/K072995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072995: Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072995
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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