510(k) · Cleared
ClearedSirolaser
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 Jan 18, 2006 as substantially equivalent to K983058 (Ceram Optec, Inc., 1998) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 1992. 79 later devices descend from it.
- Decided
- Jan 18, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922901 (1992). 10 ancestors in all. 79 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 3 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 2 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 1 generation backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- This deviceK053161 SirolaserSirona Dental Systems GmbH · 2006
- Descendant · cites it directly · 71 of its ownK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- Descendant · 2 generations on · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- Descendant · 3 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
- Descendant · 4 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · cites it directly · 27 of its ownK092660 Sirolaser AdvanceSirona Dental Systems GmbH · 2009
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K062258Genesis Diode LaserIvoclar Vivadent, Inc. · 2007 · cites it directly71descendants
- K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · 2 generations on50descendants
- K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 3 generations on35descendants
- K121286EPIC 10Biolase Technology, Inc. · 2012 · 4 generations on31descendants
- K092660Sirolaser AdvanceSirona Dental Systems GmbH · 2009 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −3 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −2 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −1 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| 0 (this device) | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| +1 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| +2 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| +3 | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
| +4 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +1 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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? (2)
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 |
|---|---|---|---|
| * | K983058 | Ceralas D Laser System, Model # Ceralas D15Summary page 2…rmware 6. BASIS FOR SUBSTANTIAL EQuI VALENCE The Sirona Dental Systems SIROLaser Device is substantially equivalent to the Cerainoptec Ceralas DI5 (K983058, K991891 ) sold latterly under the Biolitec brand name SmileProTM 980. Performance testing to validate the safety and… | 1998 |
| * | K991891 | Ceralas Diode Laser System, Model Ceralas D15Summary page 2…6. BASIS FOR SUBSTANTIAL EQuI VALENCE The Sirona Dental Systems SIROLaser Device is substantially equivalent to the Cerainoptec Ceralas DI5 (K983058, K991891 ) sold latterly under the Biolitec brand name SmileProTM 980. Performance testing to validate the safety and effect… | 1999 |
What descends from it? (79)
See all 798 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062258 | Genesis Diode Laser | 2007 | 71 |
| K092660 | Sirolaser Advance | 2009 | 27 |
| K063384 | Diodent Micro Dental Laser System, Models 810 and 980 | 2007 | 13 |
| K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W | 2010 | 8 |
| K091562 | Doctor Smile a-810 and B-980 Lasers | 2009 | 8 |
| K102036 | Doctor Surgery Diode Lasers Family | 2010 | 7 |
| K102669 | Diode Laser Therapy System | 2010 | 1 |
| K073411 | Liteduo | 2008 | 1 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K062258 (Ivoclar Vivadent, Inc., 2007) has gone furthest, with 71 descendants of its own.
- 5 other devices also cite its predicate K983058.
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?
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 epilhdml lining of frec gingiva, frenectomy frenotomy, biopsy, operculectomy, Implant recovery, gmglveulomy, 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 epilhdml lining of frec gingiva, frenectomy frenotomy, biopsy, operculectomy, Implant recovery, gmglveulomy, 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 tmpressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partiaily erupted teeth, removal of hyperplastic tissues, treatiment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket),
pulpotomy, pulpotomy as adjunct (o root canal therapy.
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/K053161 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053161: Sirolaser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053161
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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