510(k) · Cleared
ClearedQuicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quicklase Limited · GEX Powered Laser Surgical Instrument
Cleared on Mar 16, 2010 as substantially equivalent to K072995 (Lumen Development and Manufacturing, Inc., 2007) and 4 other predicates after a 26-day review. Its family tree reaches back 6 generations to 1992. 8 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 26 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K922901 (1992). 24 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 5 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 4 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 3 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 2 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 1 generation backK063384 Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc. · 2007
- This deviceK100474 Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980…Quicklase Limited · 2010
- Descendant · cites it directly · 7 of its ownK152032 ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015
- Descendant · cites it directly · 2 of its ownK193486 Epic 980Biolase, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK192617 Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK234085 LUNE™ PureHygieneEnamel Pure · 2024
- Descendant · 3 generations on · 1 of its ownK210350 Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015 · cites it directly7descendants
- K193486Epic 980Biolase, Inc. · 2020 · cites it directly2descendants
- K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020 · 2 generations on2descendants
- K234085LUNE™ PureHygieneEnamel Pure · 2024 · 2 generations on1descendant
- K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −5 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −4 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −3 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −2 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −1 | K063384 | Diodent Micro Dental Laser System, Models 810 and 980 | Hoya Conbio, Inc. | 2007 | — |
| 0 (this device) | K100474 | Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model… | Quicklase Limited | 2010 | — |
| +1 | K152032 | ELUMI 810 + 980 Soft Tissue Laser | Azena Medical, LLC | 2015 | — |
| +1 | K193486 | Epic 980 | Biolase, Inc. | 2020 | — |
| +2 | K192617 | Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC | 2020 | — |
| +2 | K234085 | LUNE™ PureHygiene | Enamel Pure | 2024 | — |
| +3 | K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021 | — |
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 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K072995 | Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser Our reading of the summary gave K072295, FDA’s number for Capnostream 20 with A2 Adaptive Averaging Software (Oridion Capnography, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TwinWave and TidalWave”. | 2007 |
| * | K063384 | Diodent Micro Dental Laser System, Models 810 and 980Summary page 2…AND DioDent Micro 980/8 10 by Hoya Conio, Inc, K063384 Odyssey Navigator Diode Laser by Ivoclar Vivadent Inc,… | 2007 |
| * | K062258 | Genesis Diode Laser | 2007 |
| * | K053161 | SirolaserSummary page 2…er by Ivoclar Vivadent Inc, ko62258 SIROLaser by Sriona Dental Systems, GmbH, K053161 LaserSmile by BioLase Technology, Inc., K030539 Device Description:… | 2006 |
| * | K030539 | LasersmileSummary page 2…SIROLaser by Sriona Dental Systems, GmbH, K053161 LaserSmile by BioLase Technology, Inc., K030539 Device Description: The laser source of the QuickLaseTmoUALDental Lasers or… | 2003 |
What descends from it? (8)
3 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 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K152032 (Azena Medical, LLC, 2015) has gone furthest, with 7 descendants of its own.
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?
For the incision, excision, ablation, vaporization, hemnostasis, and treatment of oral soft tissue. Examples: Excisional and incisional biopsies Frenectomy and Frenotomy Exposure of unerupted teeth Gingval Troughing for crown impressions Fibroma removal Gingivectomy Gingivoplasty Ginigival incision and excision Hemnostasis and coagulation Implant Recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy…
Read the full statement (175 words)
For the incision, excision, ablation, vaporization, hemnostasis, and treatment of oral soft tissue.
Examples:
Excisional and incisional biopsies Frenectomy and Frenotomy
Exposure of unerupted teeth Gingval Troughing for crown impressions
Fibroma removal Gingivectomy
Gingivoplasty Ginigival incision and excision
Hemnostasis 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 Reduction of bacterial level (decontamination) and inflammation
Soft Tissue crown lengthening Treatment of apthous ulcers
Vestibuloplasty Lesion (tumor) removal
Laser Soft Tissue Curettage Treatment of canker sores, herpetic and other ulcers of the oral mucosa
Tissue Retraction
Removal of Diseased, Infected, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithliumn
Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility
Light activation of bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100474
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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