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 Jan 26, 2007 as substantially equivalent to K030539 (Biolase Technology, Inc., 2003) and 2 other predicates after a 207-day review. Its family tree reaches back 2 generations to 2001. 289 later devices descend from it.
- Decided
- Jan 26, 2007
- Review
- 207 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011041 (2001). 4 ancestors in all. 289 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 1 generation backK030539 LasersmileBiolase Technology, Inc. · 2003
- This deviceK061898 EzlaseBiolase Technology, Inc. · 2007
- Descendant · cites it directly · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 4 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 2 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
Showing 5 of 289 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 289 · See all- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · cites it directly263descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 4 generations on70descendants
- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 2 generations on68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −1 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| 0 (this device) | K061898 | Ezlase | Biolase Technology, Inc. | 2007 | — |
| +1 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +4 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +2 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 10 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 11 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 20 | 0 |
| 2021 | 12 | 0 |
| 2022 | 26 | 0 |
| 2023 | 17 | 0 |
| 2024 | 30 | 0 |
| 2025 | 46 | 0 |
| 2026 | 23 | 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 |
|---|---|---|---|
| * | K030539 | LasersmileSummary page 3…resented herein. All the submitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in the following 510k clearances: K030539 for LaserSmileTM. K041721 for LVI Lase and K050274 for DioDent II. Conclusion: EZLaseTM is substantially equivalent to d… | 2003 |
| * | K041721 | Lvi Aesthetic LaserSummary page 3…ubmitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in the following 510k clearances: K030539 for LaserSmileTM. K041721 for LVI Lase and K050274 for DioDent II. Conclusion: EZLaseTM is substantially equivalent to dental products previously… | 2004 |
| * | K050274 | Diodent II Dental Laser SystemSummary page 3…retain the same meaning as their equivalent indications cleared by the FDA in the following 510k clearances: K030539 for LaserSmileTM. K041721 for LVI Lase and K050274 for DioDent II. Conclusion: EZLaseTM is substantially equivalent to dental products previously cleared for marketing. EZ… | 2005 |
What descends from it? (289)
See all 2895 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 6 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072034 (Quanta System Spa, 2007) has gone furthest, with 263 descendants of its own.
- 6 other devices also cite its predicate K030539.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Hemostasis and…
Read the full statement (152 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
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 mobility.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061898: Ezlase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061898
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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