510(k) Report

510(k) · Cleared

Cleared

Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100

K950019510(k) TraditionalCleared Apr 3, 199590-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

Thermolase Corp. · GEX Powered Laser Surgical Instrument

Cleared on Apr 3, 1995 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,568 later devices descend from it.

Decided
Apr 3, 1995
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

1,568 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 1997: 8 descendants cleared1998: 4 descendants cleared1999: 7 descendants cleared2015: 55 descendants cleared2017: 72 descendants cleared2019: 56 descendants cleared2000: 5 descendants cleared2003: 30 descendants cleared2004: 19 descendants cleared2002: 16 descendants cleared2006: 29 descendants cleared2005: 30 descendants cleared2007: 32 descendants cleared2008: 53 descendants cleared2016: 70 descendants cleared2013: 56 descendants cleared2011: 40 descendants cleared2009: 40 descendants cleared2020: 63 descendants cleared2012: 38 descendants cleared2001: 1 descendant cleared2010: 38 descendants cleared2023: 109 descendants cleared2018: 64 descendants cleared2022: 114 descendants cleared2024: 123 descendants cleared2014: 61 descendants cleared2021: 79 descendants cleared2025: 162 descendants cleared2026: 94 descendants cleared1995200020052010201520202025
  1. This deviceK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. Descendant · cites it directly · 1,546 of its ownK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
  3. Descendant · 2 generations on · 1,535 of its ownK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
  4. Descendant · 3 generations on · 1,526 of its ownK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
  5. Descendant · 2 generations on · 1,509 of its ownK980517 Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc. · 1998
  6. Descendant · cites it directly · 1,499 of its ownK963249 Epilight Hair Removal SystemEsc Medical Systems, Ltd. · 1997

Showing 5 of 1,568 descendants. See all descendants

Descendants cleared per year

1997: 81998: 41999: 72000: 52001: 12002: 162003: 302004: 192005: 302006: 292007: 322008: 532009: 402010: 382011: 402012: 382013: 562014: 612015: 552016: 702017: 722018: 642019: 562020: 632021: 792022: 1142023: 1092024: 1232025: 1622026: 94
1997high 162 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 1,568 · See all
  • K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997 · cites it directly1,546descendants
  • K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997 · 2 generations on1,535descendants
  • K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999 · 3 generations on1,526descendants
  • K980517Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc. · 1998 · 2 generations on1,509descendants
  • K963249Epilight Hair Removal SystemEsc Medical Systems, Ltd. · 1997 · cites it directly1,499descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp.1995—
+1K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc.1997—
+2K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1997—
+3K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1999—
+2K980517Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc.1998—
+1K963249Epilight Hair Removal SystemEsc Medical Systems, Ltd.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199780
199840
199970
200050
200110
2002160
2003300
2004190
2005300
2006290
2007320
2008530
2009400
2010380
2011400
2012380
2013560
2014610
2015550
2016700
2017720
2018640
2019560
2020630
2021790
20221140
20231090
20241230
20251620
2026940
FIG. 1 — Lineage of K950019, 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.

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? (1,568)

See all 1,568

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

NumberDeviceApplicantDecidedDescendants
K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc.19971,546
K963249Epilight Hair Removal SystemEsc Medical Systems, Ltd.19971,499
K962109SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair RemovalClassy Lady by Mehl of Puerto Rico, Inc.19971,499
K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.19971,497
K974536Photoderm HR SystemEsc Medical Systems, Ltd.19981,496
K973719Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc.1997749
K983054Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc.1999748
K150212DeScribe Transparent PFD PatchOn Light Sciences, Inc.20153

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, K963947 (Spectrum Medical Technologies, Inc., 1997) has gone furthest, with 1,546 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 Thermolase Corp.

3 FDA decisions under this applicant name. See the company

  • K993209Softlight Q-Switched ND: Yag Laser with Optional Beam-Shrinking Handpiece AccessoryThermolase Corp. · 1999
  • K971207Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 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/K950019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950019: Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950019

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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