510(k) · Cleared
ClearedOpus 10 (with Tooth Whitening Application), Model 2ND
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opusdent, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 30, 2001 after an 84-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Aug 30, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK011769 Opus 10 (with Tooth Whitening Application), Model 2NDOpusdent, Ltd. · 2001
- Descendant · cites it directly · 13 of its ownK083034 Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D. · 2009
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 3 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK230274 Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K083034Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D. · 2009 · cites it directly13descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 3 generations on2descendants
- K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011769 | Opus 10 (with Tooth Whitening Application), Model 2ND | Opusdent, Ltd. | 2001 | — |
| +1 | K083034 | Fotona XD-2 Diode Laser System, Model MD01-2F | Fotona D.D. | 2009 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +3 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +3 | K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Opus 10™ Dental Diode Laser System Named without a submission number | |
| * | — | Twilite™ Dental Diode Laser system Named without a submission number | |
| * | — | Aurora™ Diode Laser System Named without a submission number | |
| * | — | Dentek™ LD 15 Diode laser Named without a submission number |
What descends from it? (16)
See all 163 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, K083034 (Fotona D.D., 2009) has gone furthest, with 13 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 Opus 10™ Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulatien (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Opus 10™ Dental Diode Laser System include: Cosmetic Dentistry « Light activation for bleaching materials for teeth whitening «…
Read the full statement (144 words)
The Opus 10™ Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulatien (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
The Indications for Use of the Opus 10™ Dental Diode Laser System include:
Cosmetic Dentistry
« Light activation for bleaching materials for teeth whitening
« Laser-assisted bleaching/whitening of the teeth
Endodontology
e Pulpotomy
+ Pulpotomy as an adjunct to root canal therapy
Periodontology
« Sulcular debridement (removal of diseased or inflamed soft tissue n the periodental pocket)
Oral Soft Tissue Surgery
* Biopsy
» Qperculectomy
» Gingivectomy
» Gingivoplasty
« Papillectomy
Lesion (tumor) removal
» Leukoplakia
Treatment of aphthous ulcers
» Fibroma removal
* Frenectomies and frenotomies
+ Tissue retraction for impressions
» Incising and draining of abscesses
» Exposure of unerupted teeth
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/K011769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011769: Opus 10 (with Tooth Whitening Application), Model 2ND.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011769
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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