510(k) Report

510(k) · Cleared

Cleared

Medical Laser Technologies, LLC MTL Erbium:Yag Laser System

K032599510(k) TraditionalCleared Oct 29, 200365-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

Medical Laser Technologies, LLC · GEX Powered Laser Surgical Instrument

Cleared on Oct 29, 2003 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) and 2 other predicates after a 65-day review. Its family tree reaches back 4 generations to 1996. 13 later devices descend from it.

Decided
Oct 29, 2003
Review
65 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K954013 (1996). 6 ancestors in all. 13 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors2008: 3 descendants cleared2011: 3 descendants cleared2007: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant clearedK954013 · Trilase 2940 Erbium Laser · Schwartz Electro-Optics, Inc. · 1996K961748 · Medlite/Erbium Laser System · Continuum Biomedical, Inc. · 1996K980361 · Dermablate ER: Yag Laser System · Aesculap-Meditec North America · 1998K014057 · Dermastar ER:Yag Laser System · Asclepion-Meditec AG · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants K014057 · Dermastar ER:Yag Laser System · Asclepion-Meditec AG · 2002K980361 · Dermablate ER: Yag Laser System · Aesculap-Meditec North America · 1998K961748 · Medlite/Erbium Laser System · Continuum Biomedical, Inc. · 1996K954013 · Trilase 2940 Erbium Laser · Schwartz Electro-Optics, Inc. · 19960
  1. Root · 4 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
  2. 3 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
  3. 2 generations backK980361 Dermablate ER: Yag Laser SystemAesculap-Meditec North America · 1998
  4. 1 generation backK014057 Dermastar ER:Yag Laser SystemAsclepion-Meditec AG · 2002
  5. This deviceK032599 Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003
  6. Descendant · cites it directly · 2 of its ownK110897 Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC · 2011
  7. Descendant · cites it directly · 2 of its ownK110502 Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011
  8. Descendant · cites it directly · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
  9. Descendant · cites it directly · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
  10. Descendant · 2 generations on · 1 of its ownK150587 Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2007: 22008: 32011: 32013: 12015: 12016: 12022: 12024: 1
2007high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all
  • K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC · 2011 · cites it directly2descendants
  • K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011 · cites it directly2descendants
  • K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011 · cites it directly2descendants
  • K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007 · cites it directly2descendants
  • K150587Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K954013Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc.1996—
−3K961748Medlite/Erbium Laser SystemContinuum Biomedical, Inc.1996—
−2K980361Dermablate ER: Yag Laser SystemAesculap-Meditec North America1998—
−1K014057Dermastar ER:Yag Laser SystemAsclepion-Meditec AG2002—
0 (this device)K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC2003—
+1K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC2011—
+1K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC2011—
+1K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC2011—
+1K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.2007—
+2K150587Cortex Laser SystemCynosure, Inc. Dba Ellman2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200830
201130
201310
201510
201610
202210
202410
FIG. 1 — Lineage of K032599, 1996–2024Source: 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? (3)

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
*K954013Trilase 2940 Erbium Laser
Summary page 1
…Laser 79-GEX 21 CFR 878-48 hgally Marketed Predicate Schwmtz Electro-optics TriLase 2940, K#954013 Device Cell Robotics Er:YAG Laser System, KW970461 Asceplion-Meditec…
Schwartz Electro-Optics, Inc.1996—
*K970461Cell Robotics ER: Yag Surgical Laser
Summary page 1
…21 CFR 878-48 hgally Marketed Predicate Schwmtz Electro-optics TriLase 2940, K#954013 Device Cell Robotics Er:YAG Laser System, KW970461 Asceplion-Meditec Dermastar Er:YAG Laser System, K#O 14057 Description of the Device Th…
Cell Robotics, Inc.1997—
*K014057Dermastar ER:Yag Laser SystemAsclepion-Meditec AG2002—

Also cleared against K954013: 13 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112
K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112
K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112
K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072
K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071
K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080

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 7 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K110897 (Sandstone Medical Technologies, LLC, 2011) has gone furthest, with 2 descendants of its own.
  • 13 other devices also cite its predicate K954013.

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 MLT Erbium:YAG Laser System device is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.

Indications for use as stated in the FDA summary.

Also cleared against K954013

13 other devices cite the same predicate.

  • K030181International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp. · 2003
  • K021946Cell Robotics Ultra-Light Peel Laser SystemCell Robotics, Inc. · 2002
  • K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
  • K974460Lite Touch Erbium Laser Treatment SystemLorad Corp. · 1998
  • K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc. · 1997
  • K973576Epulse Model 2940 ER:Aser ER:Yag Laser SystemEpulse Technologies, Inc. · 1997

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/K032599 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032599

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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