510(k) · Cleared
ClearedSirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser
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 Feb 15, 2011 as substantially equivalent to K092660 (Sirona Dental Systems GmbH, 2009) after a 54-day review. Its family tree reaches back 7 generations to 1992. 26 later devices descend from it.
- Decided
- Feb 15, 2011
- Review
- 54 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922901 (1992). 22 ancestors in all. 26 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 6 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 5 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 4 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 3 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 2 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 1 generation backK092660 Sirolaser AdvanceSirona Dental Systems GmbH · 2009
- This deviceK103753 Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded…Sirona Dental Systems GmbH · 2011
- Descendant · cites it directly · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · cites it directly · 12 of its ownK180044 SIROLaser BlueDentsply Sirona · 2018
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 2 generations on · 6 of its ownK210367 D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K170500SIROLaser Advance+Dentsply Sirona · 2017 · cites it directly21descendants
- K180044SIROLaser BlueDentsply Sirona · 2018 · cites it directly12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022 · 2 generations on6descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −6 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −5 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −4 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −3 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −1 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| 0 (this device) | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
| +1 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +1 | K180044 | SIROLaser Blue | Dentsply Sirona | 2018 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +2 | K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K092660 | Sirolaser AdvanceSummary page 3…Asis FOR SUBSTANTA[, EQUIjVALE.NCE The Sirona Denial Systems SlROt~aser Advance Device is Substantially equlivalent to Sirona SIROI.aser Advance (K0092660) and Biolase iLase. Performance testing… | 2009 |
| * | — | Biolase iLase Named without a submission number |
What descends from it? (26)
See all 264 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 19 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K170500 (Dentsply Sirona, 2017) has gone furthest, with 21 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. 2011, 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;marginal and interdental gingival 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 epithelia] lining ; incisions…
Read the full statement (316 words)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue;marginal and interdental gingival 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 epithelia] lining ; incisions and draining of abscesses; tissue retraction for impressions papillectomy ; vestibuloplasty ; excision of lesions ; exposure of unenipted/partially erupted teeth ; removal of hyperplastic tissues ;treatment of aphthous ulcers ; leukoplakia ;Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamned and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotorny as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;.
Intra- and extra-oral surgery including incision excision hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival 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 ;incisions and draining of abscesses; tissue retraction for impressions ;papillectomy ; vestibuloplasty ;excision of lesions ; exposure of uneruptedlpartially erupted teeth ;removal of hyperplastic tissues ; treatment of aphthous ulcers; leukoplakia ; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotemy as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;
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/K103753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103753
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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