510(k) · Cleared
Recalled · 2007Denlaser, Model 800
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 Jan 25, 2001 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 87 later devices descend from it. It has been recalled 12 times.
- Decided
- Jan 25, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 12
- Predicates
- 0
87 later devices descend from it, 1 citing it directly.
- This deviceK003541 Denlaser, Model 800CAO Group, Inc. · 2001
- Descendant · cites it directly · 86 of its ownK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- Descendant · 2 generations on · 71 of its ownK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- Descendant · 3 generations on · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- Descendant · 2 generations on · 40 of its ownK062619 Denlaser 800 PlusCAO Group, Inc. · 2006
- Descendant · 4 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005 · cites it directly86descendants
- K062258Genesis Diode LaserIvoclar Vivadent, Inc. · 2007 · 2 generations on71descendants
- K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · 3 generations on50descendants
- K062619Denlaser 800 PlusCAO Group, Inc. · 2006 · 2 generations on40descendants
- K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003541 | Denlaser, Model 800 | CAO Group, Inc. | 2001 | — |
| +1 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| +2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| +3 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| +2 | K062619 | Denlaser 800 Plus | CAO Group, Inc. | 2006 | — |
| +4 | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (87)
See all 871 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | 2005 | 86 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2007 | Not classified | Z-0271-2008 | Software design | Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions. |
| Jul 23, 2007 | Not classified | Z-0273-2008 | Software design | Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions. |
| Jul 23, 2007 | Not classified | Z-0251-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0252-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0270-2008 | Software design | Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions. |
| Jul 23, 2007 | Not classified | Z-0246-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0247-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0249-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0248-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0250-2008 | Software design | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem… |
| Jul 23, 2007 | Not classified | Z-0269-2008 | Software design | Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions. |
| Jul 23, 2007 | Not classified | Z-0272-2008 | Software design | Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050453 (Ivoclar Vivadent, Inc., 2005) has gone furthest, with 86 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.
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 | — |
https://510kreport.com/device/K003541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003541: Denlaser, Model 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003541
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026