510(k) Report

510(k) · Cleared

Cleared

SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921

K023624510(k) TraditionalCleared Jan 27, 200390-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

Surgical Laser Technologies, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 27, 2003 as substantially equivalent to K012398 (Diomed, Ltd., 2002) and 5 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it.

Decided
Jan 27, 2003
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
6

Its longest line of descent runs back 8 generations to K943450 (1995). 25 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2000: 1 other ancestor1997: 6 other ancestors1996: 4 other ancestors1995: 2 other ancestors1985: 1 other ancestor1980: 1 other ancestor2003: 2 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K012398 · Diomed 15 Diode Laser · Diomed, Ltd. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 5 other ancestors4 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K012398 · Diomed 15 Diode Laser · Diomed, Ltd. · 2002K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−50
  1. Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. 1 generation backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
  9. This deviceK023624 SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc. · 2003
  10. Descendant · cites it directly · 1 of its ownK030654 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK032805 Modification to Vascular Solutions Vari-Lase Endovenous Laser…Vascular Solutions, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · cites it directly1descendant
  • K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−7K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−6K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−5K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−4K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−3K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
−2K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
−1K012398Diomed 15 Diode LaserDiomed, Ltd.2002—
0 (this device)K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.2003—
+1K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20031
+2K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199520
199640
199760
200010
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
FIG. 1 — Lineage of K023624, 1995–2003Source: 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), 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. #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? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012398Diomed 15 Diode Laser
Summary page 2
…ry 7- I Legally Marketed Predicate Devices: Diomed 81Onm Surgical Lasers and EVLT Procedure Kit (K012398) VNUS@ClosureTMSystem (K003092) VNUS@ClosureTMSystem (K982816)…
Diomed, Ltd.2002—
*K003092Modification to Vnus Closure System
Summary page 2
…7- I Legally Marketed Predicate Devices: Diomed 81Onm Surgical Lasers and EVLT Procedure Kit (K012398) VNUS@ClosureTMSystem (K003092) VNUS@ClosureTMSystem (K982816) VNUS@ClosureTMSystem (K97452 1)…
Vnus Medical Technologies, Inc.2000—
*K982816Vnus Closure System
Summary page 2
…ces: Diomed 81Onm Surgical Lasers and EVLT Procedure Kit (K012398) VNUS@ClosureTMSystem (K003092) VNUS@ClosureTMSystem (K982816) VNUS@ClosureTMSystem (K97452 1) Ceralas D10-60 8 lOnm Diode Laser System and ELVS…
Vnus Medical Technologies, Inc.1999—
*K974521Vnus Closure System
Summary page 2
…re Kit (K012398) VNUS@ClosureTMSystem (K003092) VNUS@ClosureTMSystem (K982816) VNUS@ClosureTMSystem (K97452 1) Ceralas D10-60 8 lOnm Diode Laser System and ELVS Procedure Kit (K020835)…
Vnus Medical Technologies, Inc.1998—
*K020835Ceralas D10-60 810NM Diode Laser, Modelceralas Dio-60
Summary page 2
…16) VNUS@ClosureTMSystem (K97452 1) Ceralas D10-60 8 lOnm Diode Laser System and ELVS Procedure Kit (K020835) Ceralas D Diode 980nm Laser System (KO 13691) Description of the SLT Venous FDS products include the…
Biolitec, Inc.2002—
*K013691Ceralas D Diode Laser System, Model # D50
Summary page 3
…SLT Venous Flat Fiber Delivery System is the same or very similar to those of the legally marketed Ceralas D Diode 98Onm Laser System (K013691). Safety and Animal studies have demonstrated the substantially equivalent safe and Effectiveness: effective performanc…
Biolitec, Inc.2002—

Also cleared against K012398: 5 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20031

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 8 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
  • 1 of the 25 ancestors has a recall of any class.
  • Of its descendants, K030654 (Vascular Solutions, Inc., 2003) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K012398.

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—

What is it indicated for?

The SLT Venous Fiber is 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.

Also cleared against K012398

5 other devices cite the same predicate.

  • K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc. · 2007
  • K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
  • K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 20041 recall
  • K040921Cooltouch, Model NS 160Cooltouch, Inc. · 2004
  • K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser SystemDornier Medtech America, Inc. · 2002

More from Surgical Laser Technologies, Inc.

51 FDA decisions under this applicant name. See the company

  • K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004
  • K011409SLT Laserpro CTH Holmium Laser SystemSurgical Laser Technologies, Inc. · 2001
  • K010041SLT Diffuser FiberSurgical Laser Technologies, Inc. · 2001
  • K984018Hemosleeve, Model 4.0MM, 5.5MMSurgical Laser Technologies, Inc. · 1999
  • K983050Pneumatic Cutter SystemSurgical Laser Technologies, Inc. · 1998

Recent decisions in GEX

The GEX category page

  • K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.Ltd · 2026
  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K023624 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023624: SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023624

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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