510(k) · Cleared
ClearedGentleray 980 Diode Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America · GEX Powered Laser Surgical Instrument
Cleared on Oct 26, 2007 as substantially equivalent to K983058 (Ceram Optec, Inc., 1998) and 3 other predicates after a 72-day review. Its family tree reaches back 4 generations to 1992. 51 later devices descend from it.
- Decided
- Oct 26, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K922901 (1992). 14 ancestors in all. 51 later devices descend from it, 6 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 deviceK072262 Gentleray 980 Diode Laser SystemKavo America · 2007
- 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
- Descendant · cites it directly · 23 of its ownK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- Descendant · 2 generations on · 22 of its ownK111689 StlaseDental Photonics, Inc. · 2012
- Descendant · 3 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K092660Sirolaser AdvanceSirona Dental Systems GmbH · 2009 · cites it directly27descendants
- K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH · 2011 · 2 generations on26descendants
- K094049Stlase Diode LaserDental Photonics, Inc. · 2010 · cites it directly23descendants
- K111689StlaseDental Photonics, Inc. · 2012 · 2 generations on22descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · 3 generations on21descendants
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) | K072262 | Gentleray 980 Diode Laser System | Kavo America | 2007 | — |
| +1 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| +2 | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
| +1 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| +2 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| +3 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
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 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K983058 | Ceralas D Laser System, Model # Ceralas D15Summary page 2…y 980 Diode Laser is substantially equivalent to the Ceramoptec Ceralas DI 5 (K983058, K991891) sold latterly under the BioLitec brand name SmileProTM 980, the ADT Diola… | 1998 |
| * | K991891 | Ceralas Diode Laser System, Model Ceralas D15Summary page 2…de Laser is substantially equivalent to the Ceramoptec Ceralas DI 5 (K983058, K991891) sold latterly under the BioLitec brand name SmileProTM 980, the ADT Diolase 980 D… | 1999 |
| * | K023547 | Diolase 980 D Laser SystemSummary page 2…r the BioLitec brand name SmileProTM 980, the ADT Diolase 980 D Laser System (K023547) and the Elexxion Claros (K063152). Performance testing to validate the safety and… | 2003 |
| * | K063152 | Claros Dental Laser SystemSummary page 2…name SmileProTM 980, the ADT Diolase 980 D Laser System (K023547) and the Elexxion Claros (K063152). Performance testing to validate the safety and effectiveness of the… | 2007 |
What descends from it? (51)
See all 516 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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K092660 (Sirona Dental Systems GmbH, 2009) has gone furthest, with 27 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. 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?
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: 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…
Read the full statement (102 words)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: 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, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072262 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072262: Gentleray 980 Diode Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072262
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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