510(k) · Cleared
ClearedWavelight Auriga
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavelight Laser Technologie AG · GEX Powered Laser Surgical Instrument
Cleared on Jun 30, 2005 after a 30-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 30, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK051399 Wavelight AurigaWavelight Laser Technologie AG · 2005
- Descendant · cites it directly · 1 of its ownK090776 Megapulse Laser System and FibersRichard Wolf Medical Instruments Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK122368 Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK060752 Acmi Dur-HL Laser SystemsAcmi Corporation · 2006
Most influential descendants
Showing 3 of 3 · See all- K090776Megapulse Laser System and FibersRichard Wolf Medical Instruments Corp. · 2009 · cites it directly1descendant
- K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013 · 2 generations on0descendants
- K060752Acmi Dur-HL Laser SystemsAcmi Corporation · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051399 | Wavelight Auriga | Wavelight Laser Technologie AG | 2005 | — |
| +1 | K090776 | Megapulse Laser System and Fibers | Richard Wolf Medical Instruments Corp. | 2009 | — |
| +2 | K122368 | Waterlase Iplus All Tissue Laser | Biolase Technology, Inc. | 2013 | — |
| +1 | K060752 | Acmi Dur-HL Laser Systems | Acmi Corporation | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 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 |
|---|---|---|---|
| * | — | Dornier Medilas H Named without a submission number | |
| * | — | Lumenis Versapulse Powersuite Named without a submission number | |
| * | — | convergent Omnipulse 30 Named without a submission number | |
| * | — | Trimedyne Omnipulse Named without a submission number |
What descends from it? (3)
2 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, K090776 (Richard Wolf Medical Instruments Corp., 2009) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051399: Wavelight Auriga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051399
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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