510(k) · Cleared
ClearedOdyssey 2.4G, Denlaser Elite, Model 002-00050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 27, 2005 as substantially equivalent to K030539 (Biolase Technology, Inc., 2003) and 3 other predicates after a 94-day review. Its family tree reaches back 2 generations to 2001. 86 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K011041 (2001). 5 ancestors in all, the oldest K993285 (1999). 86 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 1 generation backK030539 LasersmileBiolase Technology, Inc. · 2003
- This deviceK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- Descendant · cites it directly · 71 of its ownK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- Descendant · 2 generations on · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- Descendant · cites it directly · 40 of its ownK062619 Denlaser 800 PlusCAO Group, Inc. · 2006
- Descendant · 3 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
- Descendant · 4 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K062258Genesis Diode LaserIvoclar Vivadent, Inc. · 2007 · cites it directly71descendants
- K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · 2 generations on50descendants
- K062619Denlaser 800 PlusCAO Group, Inc. · 2006 · cites it directly40descendants
- K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 3 generations on35descendants
- K121286EPIC 10Biolase Technology, Inc. · 2012 · 4 generations on31descendants
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) | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| +1 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| +2 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| +1 | K062619 | Denlaser 800 Plus | CAO Group, Inc. | 2006 | — |
| +3 | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
| +4 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (4)
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 5…cation: Laser Instrument, Surgical, Powered Legally Marketed Predicate Devices for Substantial Equivalence: LaserSmile, Manufactured by BioLase Technology, Inc. (K030539) DenLaser 800, Manufactured by CAO Group, Inc. (K003541) Opus 10Dental Diode Laser, Manufactured by OpusDent, Inc. (K000990)… | 2003 |
| * | K003541 | Denlaser, Model 800Summary page 5…y Marketed Predicate Devices for Substantial Equivalence: LaserSmile, Manufactured by BioLase Technology, Inc. (K030539) DenLaser 800, Manufactured by CAO Group, Inc. (K003541) Opus 10Dental Diode Laser, Manufactured by OpusDent, Inc. (K000990) Aurora SL Diode Laser, Manufactured by Premier Laser… | 2001 |
| * | K000990 | Opus 10 Dental Diode LaserSummary page 5…anufactured by BioLase Technology, Inc. (K030539) DenLaser 800, Manufactured by CAO Group, Inc. (K003541) Opus 10Dental Diode Laser, Manufactured by OpusDent, Inc. (K000990) Aurora SL Diode Laser, Manufactured by Premier Laser Systems, inc. (K993285). Rationale for Substantial Equivalence:… | 2000 |
| * | K993285 | Aurora SLSummary page 5…CAO Group, Inc. (K003541) Opus 10Dental Diode Laser, Manufactured by OpusDent, Inc. (K000990) Aurora SL Diode Laser, Manufactured by Premier Laser Systems, inc. (K993285). Rationale for Substantial Equivalence: The aforementioned laser devices and their accompanying delivery systems sha… | 1999 |
What descends from it? (86)
See all 869 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062258 | Genesis Diode Laser | 2007 | 71 |
| K062619 | Denlaser 800 Plus | 2006 | 40 |
| K062071 | Prometey, Model G1-03 | 2006 | 17 |
| K083142 | Picasso Laser System | 2009 | 16 |
| K083034 | Fotona XD-2 Diode Laser System, Model MD01-2F | 2009 | 13 |
| K103667 | Sapphire ST Portable Diode Laser | 2010 | 2 |
| K160413 | Sterling 5W Diode Laser | 2016 | 0 |
| K110079 | Spphine Plus STM 3W Diode Laser | 2011 | 0 |
| K062074 | Iridex Wireless Footswitch | 2006 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K062258 (Ivoclar Vivadent, Inc., 2007) has gone furthest, with 71 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.
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:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue
Excision and biopsy
Gingivectomy and gingivoplasty
Lesion (tumor) removal
Fibroma removal
Tissue retraction (troughing)
Aphthous ulcers
Gingival hyperplasia (excision and recontour)
Crown Lengthening
Operculectomy
Frenectomy
Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage
Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050453
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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