510(k) · Cleared
ClearedSirolaser Advance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · GEX Powered Laser Surgical Instrument
Cleared on Dec 3, 2009 as substantially equivalent to K053161 (Sirona Dental Systems GmbH, 2006) and 4 other predicates after a 97-day review. Its family tree reaches back 6 generations to 1992. 27 later devices descend from it.
- Decided
- Dec 3, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K922901 (1992). 21 ancestors in all. 27 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 5 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 4 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 3 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 2 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 1 generation backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- This deviceK092660 Sirolaser AdvanceSirona Dental Systems GmbH · 2009
- Descendant · cites it directly · 26 of its ownK103753 Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded…Sirona Dental Systems GmbH · 2011
- Descendant · 2 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · 2 generations on · 12 of its ownK180044 SIROLaser BlueDentsply Sirona · 2018
- Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 3 generations on · 6 of its ownK210367 D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH · 2011 · cites it directly26descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · 2 generations on21descendants
- K180044SIROLaser BlueDentsply Sirona · 2018 · 2 generations on12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
- K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −5 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −4 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −3 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −2 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −1 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| 0 (this device) | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| +1 | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
| +2 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +2 | K180044 | SIROLaser Blue | Dentsply Sirona | 2018 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +3 | K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 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? (5)
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 |
|---|---|---|---|
| * | K053161 | SirolaserSummary page 2…able firmware 6. BASIS FOR SUBSTANTIAL EQUIVALENCE The Sirona Dental Systems SIROLaser Advance Device is substantially equivalent to Sirona SIROLaser (K053 161), Kayo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258) and Ceramoptec Ceralas DI15 (K983058, K991 891).… | 2006 |
| * | K072262 | Gentleray 980 Diode Laser SystemSummary page 2…SUBSTANTIAL EQUIVALENCE The Sirona Dental Systems SIROLaser Advance Device is substantially equivalent to Sirona SIROLaser (K053 161), Kayo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258) and Ceramoptec Ceralas DI15 (K983058, K991 891). Performance testing to validat… | 2007 |
| * | K062258 | Genesis Diode LaserSummary page 2…Dental Systems SIROLaser Advance Device is substantially equivalent to Sirona SIROLaser (K053 161), Kayo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258) and Ceramoptec Ceralas DI15 (K983058, K991 891). Performance testing to validate the safety and effectiveness of the… | 2007 |
| * | K983058 | Ceralas D Laser System, Model # Ceralas D15Summary page 2…e is substantially equivalent to Sirona SIROLaser (K053 161), Kayo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258) and Ceramoptec Ceralas DI15 (K983058, K991 891). Performance testing to validate the safety and effectiveness of the SIROLaser Advance includes electrical… | 1998 |
| * | K991891 | Ceralas Diode Laser System, Model Ceralas D15Summary page 2…lly equivalent to Sirona SIROLaser (K053 161), Kayo Gentle Ray 980 (K072262), Ivoclar Odyssey Navigator (K062258) and Ceramoptec Ceralas DI15 (K983058, K991 891). Performance testing to validate the safety and effectiveness of the SIROLaser Advance includes electrical safety, electro… | 1999 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | 2011 | 26 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K103753 (Sirona Dental Systems GmbH, 2011) has gone furthest, with 26 descendants of its own.
- 7 other devices also cite its predicate K053161.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. Indications for use are the following applications: marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, Implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery…
Read the full statement (109 words)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
Indications for use are the following applications: marginal and interdental gingiva and epithelial lining of free gingiva, 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 deseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092660: Sirolaser Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092660
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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