510(k) · Cleared
ClearedGenesis Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 21, 2007 as substantially equivalent to K050453 (Ivoclar Vivadent, Inc., 2005) and 1 other predicate after a 229-day review. Its family tree reaches back 5 generations to 1992. 71 later devices descend from it.
- Decided
- Mar 21, 2007
- Review
- 229 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922901 (1992). 17 ancestors in all. 71 later devices descend from it, 10 citing it directly.
- Root · 5 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 4 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 3 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 2 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 1 generation backK053161 SirolaserSirona Dental Systems GmbH · 2006
- This deviceK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- Descendant · cites it directly · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- Descendant · 2 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
- Descendant · 3 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
- Descendant · 2 generations on · 26 of its ownK103753 Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded…Sirona Dental Systems GmbH · 2011
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · cites it directly50descendants
- K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 2 generations on35descendants
- K121286EPIC 10Biolase Technology, Inc. · 2012 · 3 generations on31descendants
- K092660Sirolaser AdvanceSirona Dental Systems GmbH · 2009 · cites it directly27descendants
- K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH · 2011 · 2 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −4 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −3 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −2 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −1 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| 0 (this device) | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| +1 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| +2 | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
| +3 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +1 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| +2 | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
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 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050Summary page 3…uch Screen LED Display, Membrane LCD Touch Screen Touch Pad 5 10(k) Number Pending this applicaiton K050453 K053161 Conclusion The Odyssey Navigator Diode Laser is substantially equivalent to the… | 2005 |
| * | K053161 | SirolaserSummary page 3…isplay, Membrane LCD Touch Screen Touch Pad 5 10(k) Number Pending this applicaiton K050453 K053161 Conclusion The Odyssey Navigator Diode Laser is substantially equivalent to the listed laser surgical… | 2006 |
What descends from it? (71)
See all 7110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081214 | Styla Microlaser and Stylaortho | 2008 | 50 |
| K092660 | Sirolaser Advance | 2009 | 27 |
| K113472 | Precise SHP Diode Laser | 2012 | 10 |
| K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W | 2010 | 8 |
| K102036 | Doctor Surgery Diode Lasers Family | 2010 | 7 |
| K131059 | Pioneer Elite Diode Laser | 2013 | 2 |
| K103667 | Sapphire ST Portable Diode Laser | 2010 | 2 |
| K091796 | Softlase Pro, Ortholase and Hygienelase | 2009 | 2 |
| K102669 | Diode Laser Therapy System | 2010 | 1 |
| K110079 | Spphine Plus STM 3W Diode Laser | 2011 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K081214 (Zap Lasers, LLC, 2008) has gone furthest, with 50 descendants of its own.
- 8 other devices also cite its predicate K050453.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Dental, oral, and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue
Excision and biopsy
Gingivectomy and gingivoplasty
Lesion (tumor) removal
Fibroma removal
Tissue retraction (troughing)
Aphthous ulcers
Gingival hyperplasia (excision and recontour)
Crown Lengthening
Operculectomy
Frenectomy
Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage
Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
Removal of inflamed edematous tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062258 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062258: Genesis Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062258
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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