510(k) · Cleared
ClearedSIROLaser Blue
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 Mar 8, 2018 as substantially equivalent to K170500 (Dentsply Sirona, 2017) and 1 other predicate after a 59-day review. Its family tree reaches back 19 generations to 1995. 12 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 59 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 235 ancestors in all, the oldest K800617 (1980). 12 later devices descend from it, 4 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK082938 EzlaseBiolase Technology, Inc. · 2008
- 2 generations backK121286 EPIC 10Biolase Technology, Inc. · 2012
- 1 generation backK170500 SIROLaser Advance+Dentsply Sirona · 2017
- This deviceK180044 SIROLaser BlueDentsply Sirona · 2018
- Descendant · cites it directly · 6 of its ownK210367 D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 2 generations on · 2 of its ownK230047 Medical Diode Laser SystemsGigaalaser Company, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK242755 Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB…Gigaalaser Company, Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK221712 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm…Fotona D.O.O. · 2022
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK082938 EzlaseBiolase Technology, Inc. · 2008
- 2 generations backK121286 EPIC 10Biolase Technology, Inc. · 2012
- 1 generation backK170500 SIROLaser Advance+Dentsply Sirona · 2017
- This deviceK180044 SIROLaser BlueDentsply Sirona · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022 · cites it directly6descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · cites it directly3descendants
- K230047Medical Diode Laser SystemsGigaalaser Company, Ltd. · 2024 · 2 generations on2descendants
- K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd. · 2025 · 3 generations on1descendant
- K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K082938 | Ezlase | Biolase Technology, Inc. | 2008 | — |
| −2 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| −1 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| 0 (this device) | K180044 | SIROLaser Blue | Dentsply Sirona | 2018 | — |
| +1 | K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +2 | K230047 | Medical Diode Laser Systems | Gigaalaser Company, Ltd. | 2024 | — |
| +3 | K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B… | Gigaalaser Company, Ltd. | 2025 | — |
| +2 | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Fotona D.O.O. | 2022 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K170500 | SIROLaser Advance+Summary page 4…f the SIROLaser Blue are: Primary Predicate Device Name 510(k) Company Name SIROLaser Advance+ K170500 Dentsply Sirona Secondary Predicate Device Name 510(k) Company Name SIROLaser Advance… | 2017 |
| * | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSummary page 4…K170500 Dentsply Sirona Secondary Predicate Device Name 510(k) Company Name SIROLaser Advance K103753 Sirona Dental Systems GmbH Denstply Sirona SIROLaser Blue 510(k)… | 2011 |
What descends from it? (12)
See all 124 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 23 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 10 of the 235 ancestors have a recall of any class.
- Of its descendants, K210367 (Guilin Woodpecker Medical Instrument Co., Ltd., 2022) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K170500.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Blue is intended for: (970 nm and 445 nm): 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…
Read the full statement (267 words)
The SIROLaser Blue is intended for:
(970 nm and 445 nm): 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 (970 nm and 445 nm): The SIROLaser Blue is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy (660 nm and 970 nm): The SIROLaser Blue 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180044: SIROLaser Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180044
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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