510(k) · Cleared
ClearedDornier Medilas E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Surgical Products, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 20, 1998 as substantially equivalent to K971404 (Schwartz Electro-Optics, Inc., 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1996. 56 later devices descend from it.
- Decided
- Jul 20, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954013 (1996). 8 ancestors in all. 56 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 3 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- 2 generations backK964128 MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH · 1997
- 1 generation backK971648 Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
- This deviceK981438 Dornier Medilas EDornier Surgical Products, Inc. · 1998
- Descendant · cites it directly · 53 of its ownK050317 Burane XLWavelight Laser Technologie AG · 2005
- Descendant · cites it directly · 52 of its ownK052806 BuraneWavelight Laser Technologie AG · 2005
- Descendant · 2 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 3 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 3 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K050317Burane XLWavelight Laser Technologie AG · 2005 · cites it directly53descendants
- K052806BuraneWavelight Laser Technologie AG · 2005 · cites it directly52descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 3 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −3 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −2 | K964128 | MCL 29 Dermablate Erbium Laser System | Aesculap-Meditec GmbH | 1997 | — |
| −1 | K971648 | Sharplan Erbium: Yag Laser (4020) | Sharplan Lasers, Inc. | 1997 | — |
| 0 (this device) | K981438 | Dornier Medilas E | Dornier Surgical Products, Inc. | 1998 | — |
| +1 | K050317 | Burane XL | Wavelight Laser Technologie AG | 2005 | — |
| +1 | K052806 | Burane | Wavelight Laser Technologie AG | 2005 | — |
| +2 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +3 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +3 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K971404 | Schwartz Electro-Optics, Inc. CLR 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium… Our OCR of the scanned summary read K871404, FDA’s number for Kultsure (Ncs Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser”. | 1997 |
| * | K974039 | Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystalaseSummary page 1…ivalence as well as the safety and effectiveness of its predicate devices which includes the following: Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser (K871404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971648). Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared… | 1998 |
| * | K971648 | Sharplan Erbium: Yag Laser (4020)Summary page 1…of its predicate devices which includes the following: Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser (K871404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971648). Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Dornier Surgical Products, Inc. Phone: 770-428-… | 1997 |
What descends from it? (56)
See all 564 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 2 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K050317 (Wavelight Laser Technologie AG, 2005) has gone furthest, with 53 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 Dornler Medilas E Laser is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane…
Read the full statement (129 words)
The Dornler Medilas E Laser is intended to be used in small and large joint arthroscopy,
laparoscopic procedures, general and all surgical procedures for incision/excision,
vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues
encountered in all surgical procedures are included in this indication such as, skin,
cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage,
meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The
Dornier Medilas E may also be used for skin resurfacing.
The Dornier Medilas E is indicated for use in medicine and surgery, in the following
medical specialties:
¢ Demnatology ¢ Gastroenterology
¢ Plastic Surgery ¢ ENT
¢ General Surgery ¢ Thoracic Surgery
¢ Urology ¢ Oral & Maxillofacial Surgery
¢ Gynecology ¢ Ophthalmology
¢ Pulmonary Surgery ¢ Podiatry
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/K981438 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981438: Dornier Medilas E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981438
Report an extraction error
Are you the manufacturer?
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