510(k) Report

510(k) · Cleared

Cleared

Mini-Yag Laser

K061850510(k) TraditionalCleared Sep 29, 200691-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

American Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Sep 29, 2006 as substantially equivalent to K023967 (Palomar Medical Technologies, Inc., 2003) and 5 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1995.

Decided
Sep 29, 2006
Review
91 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K950019 (1995). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestorK950019 · Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 · Thermolase Corp. · 1995K973719 · Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser · Continuum Biomedical, Inc. · 1997K983054 · Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser · Continuum Biomedical, Inc. · 1999K022709 · Medlite Q-Swithced Laser · Continuum Electro-Optics, Inc. · 20031996199820002002200420062008
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K022709 · Medlite Q-Swithced Laser · Continuum Electro-Optics, Inc. · 2003K983054 · Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser · Continuum Biomedical, Inc. · 1999K973719 · Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser · Continuum Biomedical, Inc. · 1997K950019 · Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 · Thermolase Corp. · 19950
  1. Root · 4 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 3 generations backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
  3. 2 generations backK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
  4. 1 generation backK022709 Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003
  5. This deviceK061850 Mini-Yag LaserAmerican Lasers, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp.1995—
−3K973719Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc.1997—
−2K983054Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc.1999—
−1K022709Medlite Q-Swithced LaserContinuum Electro-Optics, Inc.2003—
0 (this device)K061850Mini-Yag LaserAmerican Lasers, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200210
200310
FIG. 1 — Lineage of K061850, 1995–2006Source: 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
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What was it cleared against? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K023967Palomar Q-Yag ND:Yag Laser SystemPalomar Medical Technologies, Inc.2003—
*K022709Medlite Q-Swithced Laser
Summary page 1
…ASS: REGULATORY CLASS If LASER SAFETY CLASS: CLASS IV LASER PRODUCT PREDICATE, DEVICES; PALOMAR Q-YAG LASER SYSTEM (ICO23967) MEDLITE Q-SWITCffED Nd:YAG LASER (K(022709 & 1(983054) MIEDLITE C3 Q-SWITCREI) Nt-Y AG L45ER(K011677) MEDLITE C6 Q-SWITCHED Nd:YAG LASER (1(014234) SPV(WTRA-VXM Q-SWI…
Continuum Electro-Optics, Inc.2003—
*K983054Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser
Summary page 1
…TORY CLASS If LASER SAFETY CLASS: CLASS IV LASER PRODUCT PREDICATE, DEVICES; PALOMAR Q-YAG LASER SYSTEM (ICO23967) MEDLITE Q-SWITCffED Nd:YAG LASER (K(022709 & 1(983054) MIEDLITE C3 Q-SWITCREI) Nt-Y AG L45ER(K011677) MEDLITE C6 Q-SWITCHED Nd:YAG LASER (1(014234) SPV(WTRA-VXM Q-SWIl'IIED Nd:Y…
Continuum Biomedical, Inc.1999—
*K011677Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser
Summary page 1
…SER PRODUCT PREDICATE, DEVICES; PALOMAR Q-YAG LASER SYSTEM (ICO23967) MEDLITE Q-SWITCffED Nd:YAG LASER (K(022709 & 1(983054) MIEDLITE C3 Q-SWITCREI) Nt-Y AG L45ER(K011677) MEDLITE C6 Q-SWITCHED Nd:YAG LASER (1(014234) SPV(WTRA-VXM Q-SWIl'IIED Nd:YAG LASER (10100317) LIGHT AGE Q.-CLEAR LASER (K…
Continuum Electro-Optics, Inc.2001—
*K014234Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser
Summary page 1
…LASER SYSTEM (ICO23967) MEDLITE Q-SWITCffED Nd:YAG LASER (K(022709 & 1(983054) MIEDLITE C3 Q-SWITCREI) Nt-Y AG L45ER(K011677) MEDLITE C6 Q-SWITCHED Nd:YAG LASER (1(014234) SPV(WTRA-VXM Q-SWIl'IIED Nd:YAG LASER (10100317) LIGHT AGE Q.-CLEAR LASER (Kfl33259) DESCRIIMfON; THE MINI VAG LASER IS A…
Continuum Electro-Optics, Inc.2002—
*K000317Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM
Our reading of the summary gave K100317, FDA’s number for Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo (VATECH Co., Ltd.), decided Mar 24, 2010, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spectra-VXM Q-Switched Nd:YAG Laser”.
Tissue Medical Lasers, Inc.2000—
Kept off the family treeK033259FDA’s K033259 is Light Age Q-Clear Laser, Model 701-1101
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Light Age, Inc.2004—

Also cleared against K023967: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
  • None of the 9 ancestors has a recall.
  • 3 other devices also cite its predicate K023967.

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?

American Lasers Inc.'s a solid-state Nd:YAG laser system that provides two wavelengths, 1064nm and 532nm for the removal of black and blue tattoos as well as superficial epidermal pigmented lesions and small vascular lesions. Tattoos removal: The 532nm wavelength can be used to remove red, tan, purple, and orange tattoo inks. The 1064nm wavelength can be used to remove dark (black) and blue color inks. The 532nm wavelength can also be used for removal of…

Read the full statement (153 words)

American Lasers Inc.'s a solid-state Nd:YAG laser system that provides two wavelengths, 1064nm and 532nm for the removal of black and blue tattoos as well as superficial epidermal pigmented lesions and small vascular lesions.

Tattoos removal:

The 532nm wavelength can be used to remove red, tan, purple, and orange tattoo inks.

The 1064nm wavelength can be used to remove dark (black) and blue color inks.

The 532nm wavelength can also be used for removal of superficial benign, pigmented skin lesions such as lentigines and cafe-au-lait, treatment of common nevi, and seborrheic keratoses. Also the 532nm wavelength can be used to remove small vascular lesions such as telangiectasias, small facial and leg veins, angiomas, hemangiomas, port-wine stains, and most other benign pigmented lesions such as lentigines and ephelides.

The 1064nm wavelength can also be used to treat pigmented lesions such as the nevus of Ota, removal or lightening of hair, treatment of common nevi.

Indications for use as stated in the FDA summary.

Also cleared against K023967

3 other devices cite the same predicate.

  • K053139Fotona QX ND:Yag/KTP Laser SystemFotona D.D. · 2006
  • K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
  • K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc. · 2004

More from American Lasers, Inc.

5 FDA decisions under this applicant name. See the company

  • K974142HM-RubyAmerican Lasers, Inc. · 1998
  • K970475MM-RubyAmerican Lasers, Inc. · 1997
  • K950826AM RubyAmerican Lasers, Inc. · 1995
  • K950825AM-YAGAmerican Lasers, Inc. · 1995

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/K061850 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061850: Mini-Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061850

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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