510(k) · Cleared
ClearedOdyssey HO:Yag Surgical Laser Systems & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xintec Corporation · GEX Powered Laser Surgical Instrument
Cleared on Dec 27, 1995 after a 247-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 480 later devices descend from it.
- Decided
- Dec 27, 1995
- Review
- 247 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
480 later devices descend from it, 3 citing it directly.
- This deviceK951910 Odyssey HO:Yag Surgical Laser Systems & AccessoriesXintec Corporation · 1995
- Descendant · cites it directly · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- Descendant · cites it directly · 233 of its ownK060114 Vectra Laser SystemXintec Corporation, Dba, · 2006
- Descendant · 2 generations on · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Showing 5 of 480 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 480 · See all- K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · cites it directly342descendants
- K060114Vectra Laser SystemXintec Corporation, Dba, · 2006 · cites it directly233descendants
- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on229descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 3 generations on177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951910 | Odyssey HO:Yag Surgical Laser Systems & Accessories | Xintec Corporation | 1995 | — |
| +1 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| +1 | K060114 | Vectra Laser System | Xintec Corporation, Dba, | 2006 | — |
| +2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 13 | 0 |
| 2009 | 9 | 0 |
| 2010 | 18 | 0 |
| 2011 | 17 | 0 |
| 2012 | 23 | 0 |
| 2013 | 25 | 0 |
| 2014 | 23 | 0 |
| 2015 | 23 | 0 |
| 2016 | 33 | 0 |
| 2017 | 20 | 0 |
| 2018 | 24 | 0 |
| 2019 | 20 | 0 |
| 2020 | 29 | 0 |
| 2021 | 20 | 0 |
| 2022 | 31 | 0 |
| 2023 | 23 | 0 |
| 2024 | 31 | 0 |
| 2025 | 43 | 0 |
| 2026 | 34 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (480)
See all 4803 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?
- Of its descendants, K011703 (Lumenis, 2001) has gone furthest, with 342 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/K951910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951910: Odyssey HO:Yag Surgical Laser Systems & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951910
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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