510(k) · Cleared
ClearedDornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems
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 19, 2002 as substantially equivalent to K963969 (Indigo Medical, Inc., 1997) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1996. 305 later devices descend from it.
- Decided
- Aug 19, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K955758 (1996). 6 ancestors in all. 305 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955758 Indigo Medical Model Idl 830EIndigo Medical, Inc. · 1996
- 1 generation backK982629 Dornier Medilas DDornier Surgical Products, Inc. · 1998
- This deviceK021724 Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D…Dornier Medtech America, Inc. · 2002
- Descendant · cites it directly · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 2 generations on · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 2 generations on · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · cites it directly · 197 of its ownK070536 Medilas D Family LasersDornier Medtech America, Inc. · 2007
Showing 5 of 305 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 305 · See all- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · cites it directly299descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
- K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on230descendants
- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on229descendants
- K070536Medilas D Family LasersDornier Medtech America, Inc. · 2007 · cites it directly197descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955758 | Indigo Medical Model Idl 830E | Indigo Medical, Inc. | 1996 | — |
| −1 | K982629 | Dornier Medilas D | Dornier Surgical Products, Inc. | 1998 | — |
| 0 (this device) | K021724 | Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse… | Dornier Medtech America, Inc. | 2002 | — |
| +1 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +2 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +1 | K070536 | Medilas D Family Lasers | Dornier Medtech America, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 12 | 0 |
| 2022 | 26 | 0 |
| 2023 | 17 | 0 |
| 2024 | 30 | 0 |
| 2025 | 46 | 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? (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 |
|---|---|---|---|
| * | K963969 | Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options…Summary page 2…Proprietaw to Dornier MedTech America, Inc. 3. Predicate Devices > Indigo 830e Laseroptic Treatment System with Diffuser-TipTMFiberoptic (K963969) > Dornier Medi/asTMD Fibertom Laser System (K982629) > Dornier Medi/asm D SkinPu/seTMLaser System (K000072)… | 1997 |
| * | K982629 | Dornier Medilas DSummary page 1…lowing: Indigo 830e Laseroptic Treatment System with Diffuser-TipTMFiberoptic as well as the Dornier Diode Lasers themselves, Dornier Medi/asTM D Fibertorn Laser System (K982629), Dornier Medi/asm D SkinPu/sem Laser System (K000072)and Dornier Medi/asm D SkinPu/seTMS Laser System (K003993). I. Submitt… | 1998 |
| * | K000072 | Dornier Medilas D SkinpulseSummary page 1…iffuser-TipTMFiberoptic as well as the Dornier Diode Lasers themselves, Dornier Medi/asTM D Fibertorn Laser System (K982629), Dornier Medi/asm D SkinPu/sem Laser System (K000072)and Dornier Medi/asm D SkinPu/seTMS Laser System (K003993). I. Submitter’s Name, Address, Telephone Number, Contact Person a… | 2000 |
| * | K003993 | Dornier Medilas D Skinpulse Laser System (Skinpulse)Summary page 1…s themselves, Dornier Medi/asTM D Fibertorn Laser System (K982629), Dornier Medi/asm D SkinPu/sem Laser System (K000072)and Dornier Medi/asm D SkinPu/seTMS Laser System (K003993). I. Submitter’s Name, Address, Telephone Number, Contact Person and Dat Prepared Dornier MedTech America, In… | 2001 |
What descends from it? (305)
See all 3052 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 6 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K053540 (Intermedic Arfran, SA, 2006) has gone furthest, with 299 descendants of its own.
- 2 other devices also cite its predicate K963969.
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 Diode Laser family, Medilas™ D Fibertom Laser (“Medilas D”), Medilas™ D SkinPulse™ (“SkinPulse”) and Medilas D SkinPulse™ S (“SkinPulse S“), with ITT Light Guide or Light Guide with bare fiber (fiber diameter 400pm or 600pm) are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in…
Read the full statement (168 words)
The Dornier Diode Laser family, Medilas™ D Fibertom Laser (“Medilas D”), Medilas™ D SkinPulse™ (“SkinPulse”) and Medilas D SkinPulse™ S (“SkinPulse S“), with ITT Light Guide or Light Guide with bare fiber (fiber diameter 400pm or 600pm) are intended for use in the treatment of symptoms due to urinary outflow 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.
The Dornier Diode Laser family, Medilas™ D Fibertom Laser (“Medilas D”), Medilas™ D SkinPulse™ (“SkinPulse”) and Medilas D SkinPulse™ S (“SkinPulse S“),are intended 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 SkinPulse™and SkinPulse™ S lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021724: Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021724
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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