510(k) · Cleared
ClearedDiodent II Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoya Photonics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 29, 2005 after an 81-day review. The FDA summary names its predicate without a number. 297 later devices descend from it.
- Decided
- Apr 29, 2005
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
297 later devices descend from it, 2 citing it directly.
- This deviceK050274 Diodent II Dental Laser SystemHoya Photonics, Inc. · 2005
- Descendant · cites it directly · 289 of its ownK061898 EzlaseBiolase Technology, Inc. · 2007
- Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 4 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 5 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Showing 5 of 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · See all- K061898EzlaseBiolase Technology, Inc. · 2007 · cites it directly289descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 4 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 5 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050274 | Diodent II Dental Laser System | Hoya Photonics, Inc. | 2005 | — |
| +1 | K061898 | Ezlase | Biolase Technology, Inc. | 2007 | — |
| +2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +4 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +5 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 12 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 14 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 21 | 0 |
| 2021 | 12 | 0 |
| 2022 | 26 | 0 |
| 2023 | 17 | 0 |
| 2024 | 30 | 0 |
| 2025 | 46 | 0 |
| 2026 | 23 | 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? (7)
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 |
|---|---|---|---|
| * | — | DioDent Dental Laser System Named without a submission number | |
| * | — | LVllase Named without a submission number | |
| * | — | Aurora Named without a submission number | |
| * | — | Twilite Named without a submission number | |
| * | — | Dentek LD-15 Diode Laser System Named without a submission number | |
| * | — | DioLase ST Named without a submission number | |
| * | — | Dental Diode Laser Named without a submission number |
What descends from it? (297)
See all 2972 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?
- Of its descendants, K061898 (Biolase Technology, Inc., 2007) has gone furthest, with 289 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?
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal…
Read the full statement (122 words)
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Sucular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Treatment of aphthous ulcers
Vestibuloplasty
Biopsy incision and excision
Lesion (tumor) removal
For light activation for bleaching materials for teeth whitening
For laser-assisted bleaching/whitening for teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050274 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050274: Diodent II Dental Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050274
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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