510(k) · Cleared
ClearedDornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System
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 Oct 25, 2002 as substantially equivalent to K012398 (Diomed, Ltd., 2002) and 3 other predicates after a 266-day review. Its family tree reaches back 8 generations to 1995. 695 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 266 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K943450 (1995). 28 ancestors in all, the oldest K800617 (1980). 695 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- This deviceK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- Descendant · cites it directly · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 3 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · 2 generations on · 456 of its ownK052324 Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005
- Descendant · 3 generations on · 301 of its ownK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
Showing 5 of 695 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 695 · See all- K030186Polris LVSyneron Medical, Ltd. · 2003 · cites it directly680descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 2 generations on678descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 3 generations on476descendants
- K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005 · 2 generations on456descendants
- K041959Polaris DS/CometSyneron Medical, Ltd. · 2004 · 3 generations on301descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| 0 (this device) | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
| +1 | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +2 | K052324 | Polaris LV, Lva Applicator | Syneron Medical, Ltd. | 2005 | — |
| +3 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 18 | 0 |
| 2009 | 17 | 0 |
| 2010 | 19 | 0 |
| 2011 | 15 | 0 |
| 2012 | 17 | 0 |
| 2013 | 21 | 0 |
| 2014 | 29 | 0 |
| 2015 | 25 | 0 |
| 2016 | 39 | 0 |
| 2017 | 35 | 0 |
| 2018 | 35 | 0 |
| 2019 | 25 | 0 |
| 2020 | 40 | 0 |
| 2021 | 32 | 0 |
| 2022 | 51 | 0 |
| 2023 | 45 | 0 |
| 2024 | 76 | 0 |
| 2025 | 88 | 0 |
| 2026 | 52 | 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 |
|---|---|---|---|
| * | K012398 | Diomed 15 Diode Laser | 2002 |
| * | K982629 | Dornier Medilas DSummary page 1…eness of its predicate device which includes the following: Diomed 810 nm Surgical Lasers as well as the Dornier diode lasers themselves, Dornier Medilas D Laser System (K982629), Dornier Medilas D Skinpulse Laser System (K000072) and Dornier Medilas D SkinPulse S Laser System (K003993). Submitter’s Name,… | 1998 |
| * | K000072 | Dornier Medilas D SkinpulseSummary page 1…lowing: Diomed 810 nm Surgical Lasers as well as the Dornier diode lasers themselves, Dornier Medilas D Laser System (K982629), Dornier Medilas D Skinpulse Laser System (K000072) and Dornier Medilas D SkinPulse S Laser System (K003993). Submitter’s Name, Address, Telephone Number, Contact Person and Date… | 2000 |
| * | K003993 | Dornier Medilas D Skinpulse Laser System (Skinpulse)Summary page 1…ier diode lasers themselves, Dornier Medilas D Laser System (K982629), Dornier Medilas D Skinpulse Laser System (K000072) and Dornier Medilas D SkinPulse S Laser System (K003993). Submitter’s Name, Address, Telephone Number, Contact Person and Date Prepared Dornier MedTech America, Inc.… | 2001 |
What descends from it? (695)
See all 6955 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 7 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K030186 (Syneron Medical, Ltd., 2003) has gone furthest, with 680 descendants of its own.
- 5 other devices also cite its predicate K012398.
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?
Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072, KO03993 and K021724. The Dornier Diode Laser family, MedilasTM D Fibertom Laser (“Medilas D”), MedilasrM D SkinulseTM(“SkinPulse”) and MedilasTMD SkinPulseTMS (“SkinPulse Sf),are intended for use in the treatment of symptoms due to urinary oufflow obstruction secondary to benign prostatic…
Read the full statement (237 words)
Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072, KO03993 and K021724. The Dornier Diode Laser family, MedilasTM D Fibertom Laser (“Medilas D”), MedilasrM D SkinulseTM(“SkinPulse”) and MedilasTMD SkinPulseTMS (“SkinPulse Sf),are intended for use in the treatment of symptoms due to urinary oufflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for 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 a handpiece). The SkinPulseTMand SkinPulseTMS lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
The Dornier Diode Family Lasers are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.
This premarket notification requests clearance for the additional indication as stated:
The Dornier diode family lasers, Medilas D Fibertom Laser (“Medilas D”), Medilas D SkinPulse (“SkinPulse”)and Medilas D SkinPulse S (“SkinPulse S’) are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020339
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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