510(k) Report

510(k) · Cleared

Cleared

SLT Thermalite Diode Laser Series, Diode 980, 810, 940

K952661510(k) TraditionalCleared Oct 6, 1995116-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 Oct 6, 1995 after a 116-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 340 devices in its family, counting itself, have a Class I recall. 339 later devices descend from it.

Decided
Oct 6, 1995
Review
116 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

339 later devices descend from it, 5 citing it directly. 2 of the 340 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2006: 2 descendants cleared2004: 2 descendants cleared2009: 9 descendants cleared2008: 9 descendants cleared2007: 7 descendants cleared2010: 10 descendants cleared2024: 32 descendants cleared2015: 15 descendants cleared, 1 with a Class I recall12012: 7 descendants cleared2020: 23 descendants cleared2019: 14 descendants cleared2025: 48 descendants cleared2018: 16 descendants cleared2023: 19 descendants cleared2011: 5 descendants cleared2013: 15 descendants cleared2017: 16 descendants cleared, 1 with a Class I recall12014: 12 descendants cleared2022: 27 descendants cleared2016: 12 descendants cleared2026: 27 descendants cleared2021: 12 descendants cleared1995200020052010201520202025
  1. This deviceK952661 SLT Thermalite Diode Laser Series, Diode 980, 810, 940Surgical Laser Technologies, Inc. · 1995
  2. Descendant · cites it directly · 306 of its ownK040294 Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004
  3. Descendant · cites it directly · 303 of its ownK042211 Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004
  4. Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  5. Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  6. Descendant · 3 generations on · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007

Showing 5 of 339 descendants. See all descendants

Descendants cleared per year

2004: 22006: 22007: 72008: 92009: 92010: 102011: 52012: 72013: 152014: 122015: 152016: 122017: 162018: 162019: 142020: 232021: 122022: 272023: 192024: 322025: 482026: 27
2004high 48 (2025) · low 0 (2005)2026

Class I recalls in this family

  • K143457 NeuroBlate System6 generations on · 2015
  • K171255 Monteris Medical NeuroBlate System6 generations on · 2017

Most influential descendants

Showing 5 of 339 · See all
  • K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004 · cites it directly306descendants
  • K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004 · cites it directly303descendants
  • K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
  • K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
  • K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 3 generations on230descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952661SLT Thermalite Diode Laser Series, Diode 980, 810, 940Surgical Laser Technologies, Inc.1995—
+1K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc.2004—
+1K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc.2004—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
+2K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200620
200770
200890
200990
2010100
201150
201270
2013150
2014120
2015151
2016120
2017161
2018160
2019140
2020230
2021120
2022270
2023190
2024320
2025480
2026270
FIG. 1 — Lineage of K952661, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

2 devices in this family have a Class I recall. 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? (339)

See all 339

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

NumberDeviceApplicantDecidedDescendants
K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc.2004306
K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc.2004303
K060304Photex Diode Laser Series, Models 980, 810 and 940Biotex, Inc.200642
K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.20087
K092197PHOTEX30 Diode Laser Series: 980, 810, 940Biotex, Inc.20092

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K040294 (Photo Medex, Inc., 2004) has gone furthest, with 306 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 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
  • K023624SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921Surgical Laser Technologies, Inc. · 2003
  • 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

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/K952661 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952661: SLT Thermalite Diode Laser Series, Diode 980, 810, 940.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952661

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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