510(k) Report

510(k) · Cleared

Cleared

Dornier Medilas D Skinpulse Laser System (Skinpulse)

K003993510(k) TraditionalCleared Mar 26, 200190-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dornier Surgical Products, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 26, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 705 later devices descend from it.

Decided
Mar 26, 2001
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

705 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2006: 4 descendants cleared2007: 8 descendants cleared2004: 2 descendants cleared2003: 3 descendants cleared2008: 19 descendants cleared2009: 18 descendants cleared2010: 19 descendants cleared2005: 2 descendants cleared2012: 17 descendants cleared2018: 35 descendants cleared2011: 16 descendants cleared2013: 22 descendants cleared2014: 29 descendants cleared2021: 32 descendants cleared2015: 25 descendants cleared2023: 45 descendants cleared2020: 40 descendants cleared2017: 35 descendants cleared2016: 40 descendants cleared2022: 51 descendants cleared2019: 25 descendants cleared2024: 76 descendants cleared2026: 52 descendants cleared2025: 88 descendants cleared200020052010201520202025
  1. This deviceK003993 Dornier Medilas D Skinpulse Laser System (Skinpulse)Dornier Surgical Products, Inc. · 2001
  2. Descendant · cites it directly · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
  3. Descendant · cites it directly · 681 of its ownK024064 Polaris DSSyneron Medical, Ltd. · 2003
  4. Descendant · 2 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
  5. Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
  6. Descendant · 4 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005

Showing 5 of 705 descendants. See all descendants

Descendants cleared per year

2002: 22003: 32004: 22005: 22006: 42007: 82008: 192009: 182010: 192011: 162012: 172013: 222014: 292015: 252016: 402017: 352018: 352019: 252020: 402021: 322022: 512023: 452024: 762025: 882026: 52
2002high 88 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 705 · See all
  • K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · cites it directly695descendants
  • K024064Polaris DSSyneron Medical, Ltd. · 2003 · cites it directly681descendants
  • K030186Polris LVSyneron Medical, Ltd. · 2003 · 2 generations on680descendants
  • K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants
  • K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 4 generations on476descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003993Dornier Medilas D Skinpulse Laser System (Skinpulse)Dornier Surgical Products, Inc.2001—
+1K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D…Dornier Medtech America, Inc.2002—
+1K024064Polaris DSSyneron Medical, Ltd.2003—
+2K030186Polris LVSyneron Medical, Ltd.2003—
+3K031671Polaris WRSyneron Medical, Ltd.2003—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200330
200420
200520
200640
200780
2008190
2009180
2010190
2011160
2012170
2013220
2014290
2015250
2016400
2017350
2018350
2019250
2020400
2021320
2022510
2023450
2024760
2025880
2026520
FIG. 1 — Lineage of K003993, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (705)

See all 705

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695
K024064Polaris DSSyneron Medical, Ltd.2003681
K021724Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc.2002305
K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299
K070536Medilas D Family LasersDornier Medtech America, Inc.2007197
K073427Medilas D Family LasersDornier Medtech America, Inc.200881
K041930Varilite Laser SystemIridex Corporation200475

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?

  • Of its descendants, K020339 (Dornier Medtech America, Inc., 2002) has gone furthest, with 695 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

More from Dornier Surgical Products, Inc.

9 FDA decisions under this applicant name. See the company

  • K000072Dornier Medilas D SkinpulseDornier Surgical Products, Inc. · 2000
  • K001243Dornier Medilas HDornier Surgical Products, Inc. · 2000
  • K993146Dornier Scanner HandpieceDornier Surgical Products, Inc. · 1999
  • K991183Dornier Lasertrode FiberDornier Surgical Products, Inc. · 1999
  • K984591Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999

Recent decisions in GEX

The GEX category page

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  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K003993 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003993: Dornier Medilas D Skinpulse Laser System (Skinpulse).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003993

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026