510(k) · Cleared
ClearedDiolase 980 D Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Dental Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 15, 2003 after a 176-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Apr 15, 2003
- Review
- 176 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 1 citing it directly.
- This deviceK023547 Diolase 980 D Laser SystemAmerican Dental Technologies, Inc. · 2003
- Descendant · cites it directly · 51 of its ownK072262 Gentleray 980 Diode Laser SystemKavo America · 2007
- Descendant · 2 generations on · 27 of its ownK092660 Sirolaser AdvanceSirona Dental Systems GmbH · 2009
- Descendant · 3 generations on · 26 of its ownK103753 Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded…Sirona Dental Systems GmbH · 2011
- Descendant · 2 generations on · 23 of its ownK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- Descendant · 3 generations on · 22 of its ownK111689 StlaseDental Photonics, Inc. · 2012
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K072262Gentleray 980 Diode Laser SystemKavo America · 2007 · cites it directly51descendants
- K092660Sirolaser AdvanceSirona Dental Systems GmbH · 2009 · 2 generations on27descendants
- K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH · 2011 · 3 generations on26descendants
- K094049Stlase Diode LaserDental Photonics, Inc. · 2010 · 2 generations on23descendants
- K111689StlaseDental Photonics, Inc. · 2012 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023547 | Diolase 980 D Laser System | American Dental Technologies, Inc. | 2003 | — |
| +1 | K072262 | Gentleray 980 Diode Laser System | Kavo America | 2007 | — |
| +2 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| +3 | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
| +2 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| +3 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | — | BioLitec Smilepro 980 nm Diode Laser Named without a submission number |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072262 | Gentleray 980 Diode Laser System | 2007 | 51 |
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, K072262 (Kavo America, 2007) has gone furthest, with 51 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.
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?
The following indications for use are the same as those approved on the predicate device. The DioLase 980 D Diode Dental Laser System is intended for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor…
Read the full statement (119 words)
The following indications for use are the same as those approved on the predicate device. The DioLase 980 D Diode Dental Laser System is intended for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Diseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023547: Diolase 980 D Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023547
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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