510(k) Report

510(k) · Cleared

Cleared

Modified MSQ Family of Lovely Light/Laser Systems

K042000510(k) TraditionalCleared Dec 21, 2004148-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 Dec 21, 2004 as substantially equivalent to K033946 (Msq (M2), Ltd., 2004) and 19 other predicates after a 148-day review. Its family tree reaches back 8 generations to 1992. 517 later devices descend from it.

Decided
Dec 21, 2004
Review
148 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
20

Its longest line of descent runs back 8 generations to K910422 (1992). 153 ancestors in all, the oldest K820106 (1982). 517 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 6 other ancestors2003: 14 other ancestors2002: 22 other ancestors2001: 19 other ancestors2000: 15 other ancestors1998: 9 other ancestors1997: 12 other ancestors1999: 7 other ancestors1996: 9 other ancestors1994: 8 other ancestors1995: 8 other ancestors1993: 8 other ancestors1991: 4 other ancestors1990: 1 other ancestor1989: 1 other ancestor1982: 1 other ancestor1988: 1 other ancestor2008: 15 descendants cleared2005: 1 descendant cleared2007: 8 descendants cleared2006: 3 descendants cleared2015: 20 descendants cleared2010: 14 descendants cleared2013: 14 descendants cleared2022: 42 descendants cleared2011: 14 descendants cleared2009: 6 descendants cleared2016: 32 descendants cleared2023: 32 descendants cleared2020: 33 descendants cleared2017: 24 descendants cleared2018: 25 descendants cleared2012: 11 descendants cleared2019: 14 descendants cleared2024: 63 descendants cleared2025: 61 descendants cleared2014: 20 descendants cleared2021: 27 descendants cleared2026: 38 descendants clearedK910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K023193 · Candela Gentle Yag Laser System · Candela Corp. · 2002K033172 · Candela Gentleyag Family of Laser Systems · Candela Corp. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 19 other ancestors2 generations back: 53 other ancestors3 generations back: 44 other ancestors4 generations back: 22 other ancestors5 generations back: 6 other ancestors6 generations back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 39 descendants3 generations forward: 59 descendants4 generations forward: 70 descendants5 generations forward: 95 descendants6 generations forward: 90 descendants7 generations forward: 73 descendants8 generations forward: 46 descendants9 generations forward: 16 descendants10 generations forward: 11 descendants11 generations forward: 2 descendants12 generations forward: 5 descendants13 generations forward: 1 descendant K033172 · Candela Gentleyag Family of Laser Systems · Candela Corp. · 2003K023193 · Candela Gentle Yag Laser System · Candela Corp. · 2002K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992−50+5+10
  1. Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 2 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
  8. 1 generation backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
  9. This deviceK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
  10. Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
  11. Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  12. Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
  13. Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
  14. Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008

Showing 5 of 517 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32007: 82008: 152009: 62010: 142011: 142012: 112013: 142014: 202015: 202016: 322017: 242018: 252019: 142020: 332021: 272022: 422023: 322024: 632025: 612026: 38
2005high 63 (2024) · low 1 (2005)2026

Most influential descendants

Showing 5 of 517 · See all
  • K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
  • K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
  • K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−7K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−6K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−5K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−4K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−2K023193Candela Gentle Yag Laser SystemCandela Corp.2002—
−1K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003—
0 (this device)K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008—
+1K060033Profile Multi-Platform SystemSciton, Inc2006—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
198910
199010
199140
199380
199480
199580
199690
1997120
199890
199970
2000150
2001190
2002220
2003140
200460

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200780
2008150
200960
2010140
2011140
2012110
2013140
2014200
2015200
2016320
2017240
2018250
2019140
2020330
2021270
2022420
2023320
2024630
2025610
2026380
FIG. 1 — Lineage of K042000, 1992–2026Source: 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? (20)

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
*K033946Lovely System
Summary page 1
…nt and Ultraviolet Dermatological Light III. Predicate Devices * MSq Family of Lovely Light/Laser Systems (K033946) * Lumenis BClear Targeted PhotoClearing System (K021762) * Innotech USA The FriendlyLight Nd:YAG Laser (K0…
Msq (M2), Ltd.2004—
*K021762Bclear
Summary page 1
…atological Light III. Predicate Devices * MSq Family of Lovely Light/Laser Systems (K033946) * Lumenis BClear Targeted PhotoClearing System (K021762) * Innotech USA The FriendlyLight Nd:YAG Laser (K033251) * Cutera Family of CoolGlide Lasers (K023954)…
Lumenis, Inc.2002—
*K033251The Friendlylight ND: Yag Lasers
Summary page 1
…ily of Lovely Light/Laser Systems (K033946) * Lumenis BClear Targeted PhotoClearing System (K021762) * Innotech USA The FriendlyLight Nd:YAG Laser (K033251) * Cutera Family of CoolGlide Lasers (K023954) * Palomar Clear LightTM Nd:YAG Laser System (K003460)…
Innotech USA, Inc.2004—
*K023954Altus Medical Coolglide Laser Systems and Accessories
Summary page 1
…Lumenis BClear Targeted PhotoClearing System (K021762) * Innotech USA The FriendlyLight Nd:YAG Laser (K033251) * Cutera Family of CoolGlide Lasers (K023954) * Palomar Clear LightTM Nd:YAG Laser System (K003460) * Candela GentleYAG Family of Laser Systems (K033172…
Altus Medical, Inc.2003—
*K003460Palomar Clear Light ND: Yag Laser System
Summary page 1
…* Innotech USA The FriendlyLight Nd:YAG Laser (K033251) * Cutera Family of CoolGlide Lasers (K023954) * Palomar Clear LightTM Nd:YAG Laser System (K003460) * Candela GentleYAG Family of Laser Systems (K033172) * Coherent Medical VersaPulse Aesthetic Surgical Las…
Palomar Medical Technologies, Inc.2001—
*K033172Candela Gentleyag Family of Laser Systems
Summary page 1
…* Cutera Family of CoolGlide Lasers (K023954) * Palomar Clear LightTM Nd:YAG Laser System (K003460) * Candela GentleYAG Family of Laser Systems (K033172) * Coherent Medical VersaPulse Aesthetic Surgical Lasers (K972347) * Hoya-ConBio Medlite C6 / C3 Q-Switched…
Candela Corp.2003—
*K972347Modified Coherent Versapulse Aesthetic Surgical Laser
Summary page 1
…ightTM Nd:YAG Laser System (K003460) * Candela GentleYAG Family of Laser Systems (K033172) * Coherent Medical VersaPulse Aesthetic Surgical Lasers (K972347) * Hoya-ConBio Medlite C6 / C3 Q-Switched Nd:YAG Lasers (K014234) * Hoya-ConBio Medlite Q-Switched Laser (K…
Lumenis, Inc.1997—
*K014234Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser
Summary page 1
…f Laser Systems (K033172) * Coherent Medical VersaPulse Aesthetic Surgical Lasers (K972347) * Hoya-ConBio Medlite C6 / C3 Q-Switched Nd:YAG Lasers (K014234) * Hoya-ConBio Medlite Q-Switched Laser (K022709) * Sciton Profile 1320 Laser System (K032459) *…
Continuum Electro-Optics, Inc.2002—
*K022709Medlite Q-Swithced Laser
Summary page 1
…aPulse Aesthetic Surgical Lasers (K972347) * Hoya-ConBio Medlite C6 / C3 Q-Switched Nd:YAG Lasers (K014234) * Hoya-ConBio Medlite Q-Switched Laser (K022709) * Sciton Profile 1320 Laser System (K032459) * New Star Lasers CoolTouch 3, CT3, and II Lasers (K031184, K0…
Continuum Electro-Optics, Inc.2003—
*K032459Profile 1320 Laser System
Summary page 1
…Hoya-ConBio Medlite C6 / C3 Q-Switched Nd:YAG Lasers (K014234) * Hoya-ConBio Medlite Q-Switched Laser (K022709) * Sciton Profile 1320 Laser System (K032459) * New Star Lasers CoolTouch 3, CT3, and II Lasers (K031184, K031954, and K030453) * New Star…
Sciton, Inc2004—
*K031184Cool Touch 3
Summary page 1
…* Hoya-ConBio Medlite Q-Switched Laser (K022709) * Sciton Profile 1320 Laser System (K032459) * New Star Lasers CoolTouch 3, CT3, and II Lasers (K031184, K031954, and K030453) * New Star Lasers CoolTouch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosu…
New Star Lasers, Inc.2003—
*K031954Cooltouch Incorporated MODELCT3 ND:Yag Surgical Laser Systems
Summary page 1
…a-ConBio Medlite Q-Switched Laser (K022709) * Sciton Profile 1320 Laser System (K032459) * New Star Lasers CoolTouch 3, CT3, and II Lasers (K031184, K031954, and K030453) * New Star Lasers CoolTouch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosure TriSta…
New Star Lasers, Inc.2003—
*K030453Cooltouch ND: Yag Laser System
Summary page 1
…Laser (K022709) * Sciton Profile 1320 Laser System (K032459) * New Star Lasers CoolTouch 3, CT3, and II Lasers (K031184, K031954, and K030453) * New Star Lasers CoolTouch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosure TriStar Aesthetic Workstation (K03…
New Star Lasers, Inc.2003—
*K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System
Summary page 1
…* New Star Lasers CoolTouch 3, CT3, and II Lasers (K031184, K031954, and K030453) * New Star Lasers CoolTouch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosure TriStar Aesthetic Workstation (K033176) * Laserscope Venus I, EL and Vela Er:YAG lasers (K974896,…
New Star Lasers, Inc.2004—
*K033176Tristar Aesthetic Workstation Laser
Summary page 1
…031184, K031954, and K030453) * New Star Lasers CoolTouch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosure TriStar Aesthetic Workstation (K033176) * Laserscope Venus I, EL and Vela Er:YAG lasers (K974896, K971843 and Other Laserscope Er:YAG Laser Clea…
Cynosure, Inc.2004—
*K974896Laserscope EL Laser System and Accessories
Summary page 1
…sers CoolTouch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosure TriStar Aesthetic Workstation (K033176) * Laserscope Venus I, EL and Vela Er:YAG lasers (K974896, K971843 and Other Laserscope Er:YAG Laser Clearances) * Innotech USA FriendlyLight Er:YAG Pulsed Laser (…
Laserscope1998—
*K971843Laserscope Vela Erbium:Yag Laser System and Accessories
Summary page 1
…Touch [1 and CT3 Nd:YAG Lasers (K040131) * Cynosure TriStar Aesthetic Workstation (K033176) * Laserscope Venus I, EL and Vela Er:YAG lasers (K974896, K971843 and Other Laserscope Er:YAG Laser Clearances) * Innotech USA FriendlyLight Er:YAG Pulsed Laser (K000023)…
Laserscope1997—
*K000023Friendly Light ER:Yag Pulsed Laser
Summary page 1
…us I, EL and Vela Er:YAG lasers (K974896, K971843 and Other Laserscope Er:YAG Laser Clearances) * Innotech USA FriendlyLight Er:YAG Pulsed Laser (K000023) * Sciton Profile-S and 3000 Er:YAG Laser Systems (K040005 & K010285) IV. Product Description The modi…
Innotech USA, Inc.2000—
*K040005Profile 2000/3000 Laser System
Summary page 1
…Laserscope Er:YAG Laser Clearances) * Innotech USA FriendlyLight Er:YAG Pulsed Laser (K000023) * Sciton Profile-S and 3000 Er:YAG Laser Systems (K040005 & K010285) IV. Product Description The modified MSq Family of Lovely Light/Laser System and Delivery Devices and…
Sciton, Inc2004—
*K010285Contour Profile Laser
Summary page 1
…scope Er:YAG Laser Clearances) * Innotech USA FriendlyLight Er:YAG Pulsed Laser (K000023) * Sciton Profile-S and 3000 Er:YAG Laser Systems (K040005 & K010285) IV. Product Description The modified MSq Family of Lovely Light/Laser System and Delivery Devices and…
Sciton, Inc2001—

Also cleared against K033946: 8 other devices →

What descends from it? (517)

See all 517

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

NumberDeviceApplicantDecidedDescendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266
K060033Profile Multi-Platform SystemSciton, Inc2006221
K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160
K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102
K072344Apl Medical SystemBios S.R.L.20076
K052354Oculase MDBiolase Technology, Inc.20065
K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083
K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.20051
K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080
K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070

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 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 5 of the 153 ancestors have a recall of any class.
  • Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 descendants of its own.
  • 8 other devices also cite its predicate K033946.

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 Lovely System models (Aria and Harmony) are intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery…

Read the full statement (990 words)

The Lovely System models (Aria and Harmony) are intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications, as follows:

DERMATOLOGY AND PLASTIC SURGERY

Lovely I (Aria), Lovely II (Harmony) & Lovely III (TBD) Models:

The Advanced Fluorescence Technology (AFT) 420-950 rum wavelengths are indicated for:

• The treatment of moderate inflammatory acne vulgaris

• The treatment of benign pigmented epidermal lesions including dysehromia, hyperpigmentation, melasma, and ephelides (freckles)

• The treatment of cutaneous lesions including warts, scars and striae

• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations

• The removal of unwanted hair and to effect stable long-term or permanent hair reduction

Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

The UV Light source (290-380nm) is indicated for:

• The treatment of leukoderma, including vitiligo (acquired leukoderma).

• The treatment of psoriasis, atopic dermatitis (eczema), and seborrheic dermatitis.

• Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The 1064 nm Nd:YAG lasers (Long Pulsed and Q-Switched) are indicated for treatment and clearance of:

• Benign vascular lesions such as, but not limited to treatment of:

Port wine stains

Hemangiomas

Warts

Superficial and deep telangiectasias (venulectasias)

Reticular veins (0.1-4.0 mm diaj of the leg

Rosacea

Venus lake

Leg veins

Spider veins

Poikiloderma of Civatte

Angiomas

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

1064 nm Nd:YAG lasers (Long Pulsed and Q-Switched) - continued:

• Benign cutaneous lesions, such as:

Warts

Scars

Striae

Psoriasis

• Benign pigmented lesions such as, but not limited to:

Lentigos (age spots),

Solar lentigos (sun spots)

Caf: au lait macules

Seborrheic keratoses

Nevi and nevus of Ota

Chloasma

Verrucae

Skin tags

Keratoses

The removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos)

Plaques

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

1064 nm Nd:YAG lasers (Long Pulsed and Q-Switched) - continued:

• Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

• The non-ablative treatment of facial wrinkles, such as, but not limited to:

Periocular wrinkles

Perioral wrinkles

• Laser skin resurfacing procedures for the treatment of:

Acne scars

Wrinkles

• Removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles

• Removal or lightening of unwanted hair (with and without adjuvant preparation)

Pseudofolliculitis barbae (PFB)

• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar

• Indicated for use on all skin types (Fitzpatrick [-IV), including tanned skin

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

The 532 nm Frequency-Doubled (FD) Nd:YAG lasers (Long Pulsed and Q-Switched) are indicated for:

• Incision, excision, ablation, vaporization of soft tissue

• Tattoo removal

Light blue

Yellow

Red

Green

• Vascular lesions

Hemanigomas (Port wine stains/ birthmarks, and cavernous, cherry, and spider hemangiormas)

Angiomas (cherry, spider)

Telangiectasia

Spider nevi

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

532 nm Frequency-Doubled (FD) Nd:YAG lasers (Long Pulsed & Q-Switched) - continued:

• Benign pigmented lesions

Caf6-au-lait (macules)

Lentigines (senile and solar)

Freckles (ephelides)

Chloasma

Nevi

Nevus spillus

Nevus of Ota

Becker's nevi

• Other pigmented cutaneous lesions

Verrucae

Skin tags

Keratoses

Plaques

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

1320 nm Nd:YAG laser is indicated for the treatment of:

• Fine lines and wrinkles

• Periorbital wrinkles

• Perioral wrinkles

• Back acne

• Atrophic acne scars

• Mild to moderate inflammatory acne vulgaris

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

2940 nm Er:YAG laser is indicated for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands):

• Skin resurfacing

• Treatment of wrinkles

• Epidermal nevi

• Telangiectasia

• Spider veins

• Actinic chelitis

• Keloids

Verrucae

• Skin tags

• Anal tags

• Keratoses

• Scar revision (including acne scars)

• Debulking benign tunmors

• Debulking cysts

• Superficial skin lesions

• Diagnostic biopsies

• Decubitis ulcers

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

2940 nm Er:YAG laser - continued:

GENERAL SURGERY:

Surgical incision/excision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated

GENITOURINARY:

Treatment of:

Lesions of the external genitalia, anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar lesions, polyps, and familial polyps of the colon

GYNECOLOGY:

Treatment of:

• Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma

DERMATOLOGY AND PLASTIC SURGERY - continued

Lovely II (Harmony) & Lovely III (TBD) Models:

2940 nm Er:YAG laser - continued:

ORAL/MAXILLOFACIAL:

Treatment of:

• Benign oral tumors, oral and glossal lesions, and gingivectomy

OTORHINOLARYNGOLOGY/ HEAD AND NECK (ENT):

Treatment of:

Ear, nose and throat lesions, polyps, cysts, hyperkeratosis

Excision of carcinogenic tissue and oral leukoplakia

OPIHTHIALMOLOGY:

Treatment of:

• Soft tissue surrounding the eye and orbit

PODIATRY:

Treatment of:

Warts, plantar verrucae, large mosaic verrucae

• Matrixectomy

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K042000: Modified MSQ Family of Lovely Light/Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042000

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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