510(k) · Cleared
ClearedDornier Medila H
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 Nov 25, 1998 as substantially equivalent to K981718 (Dornier Surgical Products, Inc., 1998) after a 19-day review. Its family tree reaches back 2 generations to 1997. 346 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 19 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964760 (1997). 346 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK964760 Dornier Medilas Fiber Tome LaserDornier Medtech America, Inc. · 1997
- 1 generation backK981718 Dornier Medilas HDornier Surgical Products, Inc. · 1998
- This deviceK983963 Dornier Medila HDornier Medtech America, Inc. · 1998
- Descendant · cites it directly · 344 of its ownK984591 Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999
- Descendant · 2 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- Descendant · 3 generations on · 136 of its ownK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
- Descendant · 3 generations on · 136 of its ownK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- Descendant · 4 generations on · 122 of its ownK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
Showing 5 of 346 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 346 · See all- K984591Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999 · cites it directly344descendants
- K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 2 generations on342descendants
- K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009 · 3 generations on136descendants
- K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009 · 3 generations on136descendants
- K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010 · 4 generations on122descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964760 | Dornier Medilas Fiber Tome Laser | Dornier Medtech America, Inc. | 1997 | — |
| −1 | K981718 | Dornier Medilas H | Dornier Surgical Products, Inc. | 1998 | — |
| 0 (this device) | K983963 | Dornier Medila H | Dornier Medtech America, Inc. | 1998 | — |
| +1 | K984591 | Dornier Medilas H/2 | Dornier Surgical Products, Inc. | 1999 | — |
| +2 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| +3 | K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers | Patholase, Inc. | 2009 | — |
| +3 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| +4 | K093545 | Pinpointe Footlaser Model 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 13 | 0 |
| 2012 | 18 | 0 |
| 2013 | 21 | 0 |
| 2014 | 15 | 0 |
| 2015 | 15 | 0 |
| 2016 | 26 | 0 |
| 2017 | 16 | 0 |
| 2018 | 15 | 0 |
| 2019 | 11 | 0 |
| 2020 | 20 | 0 |
| 2021 | 15 | 0 |
| 2022 | 19 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 32 | 0 |
| 2026 | 25 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981718 | Dornier Medilas HSummary page 2…ization with a bare fiber. The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718). The modified Medilas H and the unmodified Medilas H laser systems have photoelectric power meters and are automatically calibr… | 1998 |
What descends from it? (346)
See all 3462 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?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K984591 (Dornier Surgical Products, Inc., 1999) has gone furthest, with 344 descendants of its own.
- 2 other devices also cite its predicate K981718.
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 is indicated for use in medicine and surgery, in the following medical specialties:
Urology
Arthroscopy
General Surgery
Pulmonology
Gastroenterology
ENT
Lithotripsy
Gynecology
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983963: Dornier Medila H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983963
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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