510(k) · Cleared
ClearedDornier Medilas D 30 Laser, Medilas D 1064
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 Jun 27, 2008 as substantially equivalent to K070536 (Dornier Medtech America, Inc., 2007) and 4 other predicates after an 85-day review. Its family tree reaches back 11 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K943450 (1995). 142 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 2 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 1 generation backK063828 Diomed Delta 25Diomed, Ltd. · 2007
- This deviceK080959 Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK181510 Echolaser X4El.En Electronic Engineering Spa · 2018
- Descendant · 2 generations on · 1 of its ownK213594 Echolaser X4Elesta S.P.A · 2022
- Descendant · 3 generations on · 0 of its ownK261964 Echolaser X4Elesta S.P.A · 2026
- Descendant · 2 generations on · 0 of its ownK260632 Laser Thermal Therapy KitElesta S.P.A · 2026
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 3 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 2 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 1 generation backK063828 Diomed Delta 25Diomed, Ltd. · 2007
- This deviceK080959 Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K181510Echolaser X4El.En Electronic Engineering Spa · 2018 · cites it directly3descendants
- K213594Echolaser X4Elesta S.P.A · 2022 · 2 generations on1descendant
- K261964Echolaser X4Elesta S.P.A · 2026 · 3 generations on0descendants
- K260632Laser Thermal Therapy KitElesta S.P.A · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −3 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −2 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −1 | K063828 | Diomed Delta 25 | Diomed, Ltd. | 2007 | — |
| 0 (this device) | K080959 | Dornier Medilas D 30 Laser, Medilas D 1064 | Dornier Medtech America, Inc. | 2008 | — |
| +1 | K181510 | Echolaser X4 | El.En Electronic Engineering Spa | 2018 | — |
| +2 | K213594 | Echolaser X4 | Elesta S.P.A | 2022 | — |
| +3 | K261964 | Echolaser X4 | Elesta S.P.A | 2026 | — |
| +2 | K260632 | Laser Thermal Therapy Kit | Elesta S.P.A | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 15 | 0 |
| 1997 | 19 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 16 | 0 |
| 2001 | 15 | 0 |
| 2002 | 18 | 0 |
| 2003 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K070536 | Medilas D Family LasersSummary page 1…LiteBeam, Medilas D LiteBeam+, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse (K070536) * Diomed Delta 15 and Diomed Delta 30 (KO51996) The DornierMed… | 2007 |
| * | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | 2005 |
| * | K964760 | Dornier Medilas Fiber Tome LaserSummary page 1…tially equivalent in terms of its laser wavelength performance to · DornierMedilas Fibertome model 5100 (K964760) · Diomed Delta 25 (K063828) · Laserscope Lyra Surgical Las… | 1997 |
| * | K063828 | Diomed Delta 25Summary page 1…laser wavelength performance to · DornierMedilas Fibertome model 5100 (K964760) · Diomed Delta 25 (K063828) · Laserscope Lyra Surgical Laser System (K020021) General Device The Dornier… | 2007 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 1…Fibertome model 5100 (K964760) · Diomed Delta 25 (K063828) · Laserscope Lyra Surgical Laser System (K020021) General Device The Dornier Medilas D 1064 Laser is a continuous-wave Description: diode laser e… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181510 | Echolaser X4 | 2018 | 3 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 142 ancestors have a recall of any class.
- Of its descendants, K181510 (El.En Electronic Engineering Spa, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K070536.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with…
Read the full statement (104 words)
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties:
Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology.
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080959 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080959: Dornier Medilas D 30 Laser, Medilas D 1064.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080959
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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