510(k) · Cleared
ClearedDenlaser 800 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 14, 2006 as substantially equivalent to K050453 (Ivoclar Vivadent, Inc., 2005) and 2 other predicates after a 70-day review. Its family tree reaches back 3 generations to 2001. 40 later devices descend from it.
- Decided
- Nov 14, 2006
- Review
- 70 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011041 (2001). 7 ancestors in all, the oldest K993285 (1999). 40 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 2 generations backK030539 LasersmileBiolase Technology, Inc. · 2003
- 1 generation backK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- This deviceK062619 Denlaser 800 PlusCAO Group, Inc. · 2006
- Descendant · cites it directly · 22 of its ownK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- Descendant · cites it directly · 20 of its ownK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 10 of its ownK113472 Precise SHP Diode LaserCAO Group, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008 · cites it directly22descendants
- K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010 · cites it directly20descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K113472Precise SHP Diode LaserCAO Group, Inc. · 2012 · cites it directly10descendants
- K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −2 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| −1 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| 0 (this device) | K062619 | Denlaser 800 Plus | CAO Group, Inc. | 2006 | — |
| +1 | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| +1 | K100143 | Pilot Diode Laser, Model 002-00139 | CAO Group, Inc. | 2010 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K113472 | Precise SHP Diode Laser | CAO Group, Inc. | 2012 | — |
| +2 | K123443 | Precise SHP Diode Laser | CAO Group, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050Summary page 1…: Laser Instrument, Surgical Legally Marketed Predicate Devices for Substantial Equivalence: Odyssey 2.4G Diode Laser, manufactured by Ivoclar Vivadent. Inc. (K050453) Ceralas D 81 0 Diode Laser, manuifactured by Biolitec. Inc. (K032864) Aurora SI. Diode Laser. manufactured by Premier Laser Sy… | 2005 |
| * | K032864 | Ceralas D 810 Diode Laser System, Model D15Summary page 1…es for Substantial Equivalence: Odyssey 2.4G Diode Laser, manufactured by Ivoclar Vivadent. Inc. (K050453) Ceralas D 81 0 Diode Laser, manuifactured by Biolitec. Inc. (K032864) Aurora SI. Diode Laser. manufactured by Premier Laser Systems, Inc. (K993285) Rationale for Substantial Equivalence: T… | 2004 |
| * | K993285 | Aurora SLSummary page 1…lar Vivadent. Inc. (K050453) Ceralas D 81 0 Diode Laser, manuifactured by Biolitec. Inc. (K032864) Aurora SI. Diode Laser. manufactured by Premier Laser Systems, Inc. (K993285) Rationale for Substantial Equivalence: The aforementioned laser devices and their accompanying delivery systems share s… | 1999 |
What descends from it? (40)
See all 405 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 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K073322 (A.R.C Laser GmbH, 2008) has gone furthest, with 22 descendants of its own.
- 8 other devices also cite its predicate K050453.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DenLaser 800 Plus is indicated for the procedures of
removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation
on soft tissue in the fields of
otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, plastic surgery, urology, gynecology, and plastic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062619: Denlaser 800 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062619
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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