510(k) · Cleared
ClearedEzlase 3 Laser System
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 Mar 12, 2010 as substantially equivalent to K061898 (Biolase Technology, Inc., 2007) and 2 other predicates after an 86-day review. Its family tree reaches back 7 generations to 1992. 35 later devices descend from it.
- Decided
- Mar 12, 2010
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K922901 (1992). 29 ancestors in all. 35 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 backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- This deviceK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
- 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 · 3 generations on · 6 of its ownK210367 D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · 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
- K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. · 2022 · 3 generations on6descendants
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 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| 0 (this device) | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
| +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 | — |
| +3 | K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K061898 | EzlaseSummary page 1…lassificationCode: 79 GEX, a Class 11 device PredicateDevices: ezlase® Biolase Technology, Inc K061898 (1/26/07), K083069 (11/13/08) Styla Microlaser Zap Lasers, LLC… | 2007 |
| * | K083069 | Ezlase 10WSummary page 1…79 GEX, a Class 11 device PredicateDevices: ezlase® Biolase Technology, Inc K061898 (1/26/07), K083069 (11/13/08) Styla Microlaser Zap Lasers, LLC… | 2008 |
| * | K081214 | Styla Microlaser and StylaorthoSummary page 1…K061898 (1/26/07), K083069 (11/13/08) Styla Microlaser Zap Lasers, LLC K081214 (5/14/2008) DEVICE DESCRiPTION: The iLaselm dental soft tissue laser is a surgical device designed for awide variety of de… | 2008 |
What descends from it? (35)
See all 354 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 18 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K121286 (Biolase Technology, Inc., 2012) has gone furthest, with 31 descendants of its own.
- 4 other devices also cite its predicate K061898.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Dental Soft Tissue - Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: > Excisional and incisional biopsies > Exposure of unerupted teeth > Fibroma removal > Frenectomy > Frenotomy > Gingival troughing for crown impressions > Gingivectomy > Gingivoplasty > Gingival incision and excision…
Read the full statement (182 words)
Dental Soft Tissue - Indications for:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
> Excisional and incisional biopsies
> Exposure of unerupted teeth
> Fibroma removal
> Frenectomy
> Frenotomy
> Gingival troughing for crown impressions
> Gingivectomy
> Gingivoplasty
> Gingival incision and excision
> Hemostasis and coagulation
> Implant recovery
> Incision and drainage of abscess
> Leukoplakia
> Operculectomy
> Oral papillectomies
> Pulpotomy
> Pulpotomy as an adjunct to root canal therapy
> Reduction of gingival hypertrophy
> Soft tissue crown lengthening
> Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
> Vestibuloplasty
> Tissue retraction for impression
Laser Periodontal procedures, including:
> Laser soft tissue curettage
> 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.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093852: Ezlase 3 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/K093852
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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