510(k) Report

510(k) · Cleared

Cleared

Soprano Hair Removal Diode Laser

K052874510(k) SpecialCleared Nov 22, 200541-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

Msq (M2), Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Nov 22, 2005 as substantially equivalent to K030805 (Msq (M2), Ltd., 2003) after a 41-day review. Its family tree reaches back 2 generations to 2000. 126 later devices descend from it.

Decided
Nov 22, 2005
Review
41 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K001746 (2000). 3 ancestors in all. 126 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2010: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2014: 4 descendants cleared2012: 1 descendant cleared2016: 5 descendants cleared2018: 7 descendants cleared2013: 2 descendants cleared2026: 9 descendants cleared2015: 6 descendants cleared2022: 15 descendants cleared2019: 9 descendants cleared2020: 13 descendants cleared2025: 15 descendants cleared2017: 3 descendants cleared2023: 10 descendants cleared2024: 13 descendants cleared2021: 11 descendants clearedK001746 · Lightsheer Pulsed Diode Array Laser System (Family of Products) · Coherent Star · 2000K030805 · Mythos 500 · Msq (M2), Ltd. · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 15 descendants4 generations forward: 30 descendants5 generations forward: 38 descendants6 generations forward: 22 descendants7 generations forward: 9 descendants8 generations forward: 5 descendants9 generations forward: 1 descendant K030805 · Mythos 500 · Msq (M2), Ltd. · 2003K001746 · Lightsheer Pulsed Diode Array Laser System (Family of Products) · Coherent Star · 20000+5
  1. Root · 2 generations backK001746 Lightsheer Pulsed Diode Array Laser System (Family of Products)Coherent Star · 2000
  2. 1 generation backK030805 Mythos 500Msq (M2), Ltd. · 2003
  3. This deviceK052874 Soprano Hair Removal Diode LaserMsq (M2), Ltd. · 2005
  4. Descendant · cites it directly · 125 of its ownK083848 Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd. · 2009
  5. Descendant · cites it directly · 124 of its ownK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
  6. Descendant · 2 generations on · 118 of its ownK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
  7. Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
  8. Descendant · 3 generations on · 53 of its ownK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013

Showing 5 of 126 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12012: 12013: 22014: 42015: 62016: 52017: 32018: 72019: 92020: 132021: 112022: 152023: 102024: 132025: 152026: 9
2009high 15 (2022) · low 1 (2009)2026

Most influential descendants

Showing 5 of 126 · See all
  • K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd. · 2009 · cites it directly125descendants
  • K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010 · cites it directly124descendants
  • K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc. · 2011 · 2 generations on118descendants
  • K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
  • K123483Diode LaserBeijing Syntech Laser CO., LTD. · 2013 · 3 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001746Lightsheer Pulsed Diode Array Laser System (Family of Products)Coherent Star2000—
−1K030805Mythos 500Msq (M2), Ltd.2003—
0 (this device)K052874Soprano Hair Removal Diode LaserMsq (M2), Ltd.2005—
+1K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd.2009—
+1K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010—
+2K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with…Alma Lasers, Inc.2011—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.2014—
+3K123483Diode LaserBeijing Syntech Laser CO., LTD.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201210
201320
201440
201560
201650
201730
201870
201990
2020130
2021110
2022150
2023100
2024130
2025150
202690
FIG. 1 — Lineage of K052874, 2000–2026Source: 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), 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? (1)

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
*K030805Mythos 500
Summary page 1
…ary Classification Name: Surgical Powered Laser Instrument 3. Predicate Device * MSq MYTHOSTm Hair Removal Diode Laser System (K030805) 4. Product Description The modified MSq SOPRANO Tm Hair Removal Diode Laser System is comprised of the following compon…
Msq (M2), Ltd.2003—

Also cleared against K030805: 1 other device →

What descends from it? (126)

See all 126

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

NumberDeviceApplicantDecidedDescendants
K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd.2009125
K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124

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 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K083848 (Alma Lasers, Ltd., 2009) has gone furthest, with 125 descendants of its own.
  • 1 other device also cites its predicate K030805.

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 SOPRANOTM Hair Removal Diode Laser is intended for hair removal and permanent hair reduction.

The SOPRANOTM System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Indications for use as stated in the FDA summary.

Also cleared against K030805

1 other device cites the same predicate.

  • K041959Polaris DS/CometSyneron Medical, Ltd. · 2004

More from Msq (M2), Ltd.

5 FDA decisions under this applicant name. See the company

  • K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
  • K033946Lovely SystemMsq (M2), Ltd. · 2004
  • K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd. · 2003
  • K030805Mythos 500Msq (M2), Ltd. · 2003

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/K052874 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052874: Soprano Hair Removal Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052874

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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