510(k) · Cleared
ClearedDornier Medilas H Laser Fiber Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 21, 2002 after a 20-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Aug 21, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
6 later devices descend from it, 3 citing it directly.
- This deviceK022544 Dornier Medilas H Laser Fiber CablesDornier Medtech America, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK121938 Medilas H Rfid Laser FiberDornier Medtech America, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK152591 Medilas H RFID Laser FibersDornier Medtech America, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK090776 Megapulse Laser System and FibersRichard Wolf Medical Instruments Corp. · 2009
- Descendant · 3 generations on · 0 of its ownK161771 Medilas H Laser FibersDornier Medtech America, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK122368 Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc. · 2012 · cites it directly3descendants
- K152591Medilas H RFID Laser FibersDornier Medtech America, Inc. · 2015 · 2 generations on1descendant
- K090776Megapulse Laser System and FibersRichard Wolf Medical Instruments Corp. · 2009 · cites it directly1descendant
- K161771Medilas H Laser FibersDornier Medtech America, Inc. · 2016 · 3 generations on0descendants
- K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022544 | Dornier Medilas H Laser Fiber Cables | Dornier Medtech America, Inc. | 2002 | — |
| +1 | K121938 | Medilas H Rfid Laser Fiber | Dornier Medtech America, Inc. | 2012 | — |
| +2 | K152591 | Medilas H RFID Laser Fibers | Dornier Medtech America, Inc. | 2015 | — |
| +1 | K090776 | Megapulse Laser System and Fibers | Richard Wolf Medical Instruments Corp. | 2009 | — |
| +3 | K161771 | Medilas H Laser Fibers | Dornier Medtech America, Inc. | 2016 | — |
| +2 | K122368 | Waterlase Iplus All Tissue Laser | Biolase Technology, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K980685 | FDA’s K980685 is Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
What descends from it? (6)
3 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, K121938 (Dornier Medtech America, Inc., 2012) has gone furthest, with 3 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 | — |
What is it indicated for?
The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022544: Dornier Medilas H Laser Fiber Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022544
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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