510(k) · Cleared
ClearedSIROLaser Advance+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · GEX Powered Laser Surgical Instrument
Cleared on May 16, 2017 as substantially equivalent to K121286 (Biolase Technology, Inc., 2012) and 2 other predicates after an 84-day review. Its family tree reaches back 18 generations to 1995. 21 later devices descend from it.
- Decided
- May 16, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K943450 (1995). 234 ancestors in all, the oldest K800617 (1980). 21 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK082938 EzlaseBiolase Technology, Inc. · 2008
- 1 generation backK121286 EPIC 10Biolase Technology, Inc. · 2012
- This deviceK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · cites it directly · 12 of its ownK180044 SIROLaser BlueDentsply Sirona · 2018
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK082938 EzlaseBiolase Technology, Inc. · 2008
- 1 generation backK121286 EPIC 10Biolase Technology, Inc. · 2012
- This deviceK170500 SIROLaser Advance+Dentsply Sirona · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K180044SIROLaser BlueDentsply Sirona · 2018 · cites it directly12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022 · cites it directly6descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K082938 | Ezlase | Biolase Technology, Inc. | 2008 | — |
| −1 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| 0 (this device) | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +1 | K180044 | SIROLaser Blue | Dentsply Sirona | 2018 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | 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 | — |
| +2 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 16 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 16 | 0 |
| 2001 | 17 | 0 |
| 2002 | 22 | 0 |
| 2003 | 19 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K121286 | EPIC 10Summary page 4…for the SIROLaser Advance+ are: Primary Predicate Device Name 510(k) Company Name Epic 10 K121286 Biolase Technology, Inc. Additional Predicate Devices 510(k) Company Name SIROLaser Advan… | 2012 |
| * | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSummary page 4…86 Biolase Technology, Inc. Additional Predicate Devices 510(k) Company Name SIROLaser Advance K103753 Sirona Dental Systems GmbH THOR VR Single Diode Laser Treatment Probe K070024 THOR International Tradit… | 2011 |
| * | K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode ProbeSummary page 4…) Company Name SIROLaser Advance K103753 Sirona Dental Systems GmbH THOR VR Single Diode Laser Treatment Probe K070024 THOR International Traditional 510(k): SIROLaser Advance+ Dentsply Sirona 4. Description of Device:… | 2007 |
What descends from it? (21)
See all 213 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 22 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 10 of the 234 ancestors have a recall of any class.
- Of its descendants, K180044 (Dentsply Sirona, 2018) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K121286.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The SIROLaser Advance+ is intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted…
Read the full statement (252 words)
The SIROLaser Advance+ is intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and is indicated for: 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 diseased 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; 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; pulpotomy 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.
Whitening: The SIROLaser Advance+ is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: The SIROLaser Advance+ is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170500: SIROLaser Advance+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170500
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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