510(k) · Cleared
ClearedEzlase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 22, 2008 as substantially equivalent to K003385 (Biolase Technology, Inc., 2001) and 4 other predicates after an 81-day review. Its family tree reaches back 16 generations to 1995. 50 later devices descend from it.
- Decided
- Dec 22, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K943450 (1995). 169 ancestors in all, the oldest K800617 (1980). 50 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- This deviceK082938 EzlaseBiolase Technology, Inc. · 2008
- Descendant · cites it directly · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · 2 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · 3 generations on · 12 of its ownK180044 SIROLaser BlueDentsply Sirona · 2018
- Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- This deviceK082938 EzlaseBiolase Technology, Inc. · 2008
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K121286EPIC 10Biolase Technology, Inc. · 2012 · cites it directly31descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · 2 generations on21descendants
- K180044SIROLaser BlueDentsply Sirona · 2018 · 3 generations on12descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
- K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −2 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| 0 (this device) | K082938 | Ezlase | Biolase Technology, Inc. | 2008 | — |
| +1 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +2 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +3 | K180044 | SIROLaser Blue | Dentsply Sirona | 2018 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K123443 | Precise SHP Diode Laser | CAO Group, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 18 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K003385 | Twilite, Twilite WhiteSummary page 2…ations for use (K061898) to include teeth whitening, an indication already cleared by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (TwiliteTM), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (VectraTM). Based on this comparison, the ez/aseTM… | 2001 |
| * | K993002 | Ceralas D 980NM Diode Laser System, Model D15Summary page 2…98) to include teeth whitening, an indication already cleared by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (TwiliteTM), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (VectraTM). Based on this comparison, the ez/aseTM is substantially equ… | 1999 |
| * | K050824 | 100W Ceralas D 980 Laser System, Model D100Summary page 2…clude teeth whitening, an indication already cleared by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (TwiliteTM), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (VectraTM). Based on this comparison, the ez/aseTM is substantially equivalent i… | 2005 |
| * | K072106 | 150W Ceralas D 980NM Diode LaserSummary page 2…th whitening, an indication already cleared by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (TwiliteTM), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (VectraTM). Based on this comparison, the ez/aseTM is substantially equivalent in relatio… | 2007 |
| * | K060114 | Vectra Laser SystemSummary page 2…red by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (TwiliteTM), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (VectraTM). Based on this comparison, the ez/aseTM is substantially equivalent in relation to previous cleared devices. CONCLUSI… | 2006 |
What descends from it? (50)
See all 505 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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 7 of the 169 ancestors have a recall of any class.
- Of its descendants, K121286 (Biolase Technology, Inc., 2012) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K003385.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Light activation for bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082938: Ezlase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082938
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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