510(k) · Cleared
ClearedModified MSQ Family of Lovely Light/Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 1 generation backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- This deviceK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −1 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| 0 (this device) | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 12 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 22 | 0 |
| 2003 | 14 | 0 |
| 2004 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 6 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 20 | 0 |
| 2015 | 20 | 0 |
| 2016 | 32 | 0 |
| 2017 | 24 | 0 |
| 2018 | 25 | 0 |
| 2019 | 14 | 0 |
| 2020 | 33 | 0 |
| 2021 | 27 | 0 |
| 2022 | 42 | 0 |
| 2023 | 32 | 0 |
| 2024 | 63 | 0 |
| 2025 | 61 | 0 |
| 2026 | 38 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033946 | Lovely SystemSummary 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… | 2004 |
| * | K021762 | BclearSummary 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)… | 2002 |
| * | K033251 | The Friendlylight ND: Yag LasersSummary 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)… | 2004 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary 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… | 2003 |
| * | K003460 | Palomar Clear Light ND: Yag Laser SystemSummary 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… | 2001 |
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary 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… | 2003 |
| * | K972347 | Modified Coherent Versapulse Aesthetic Surgical LaserSummary 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… | 1997 |
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary 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) *… | 2002 |
| * | K022709 | Medlite Q-Swithced LaserSummary 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… | 2003 |
| * | K032459 | Profile 1320 Laser SystemSummary 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… | 2004 |
| * | K031184 | Cool Touch 3Summary 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… | 2003 |
| * | K031954 | Cooltouch Incorporated MODELCT3 ND:Yag Surgical Laser SystemsSummary 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… | 2003 |
| * | K030453 | Cooltouch ND: Yag Laser SystemSummary 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… | 2003 |
| * | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemSummary 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,… | 2004 |
| * | K033176 | Tristar Aesthetic Workstation LaserSummary 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… | 2004 |
| * | K974896 | Laserscope EL Laser System and AccessoriesSummary 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 (… | 1998 |
| * | K971843 | Laserscope Vela Erbium:Yag Laser System and AccessoriesSummary 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)… | 1997 |
| * | K000023 | Friendly Light ER:Yag Pulsed LaserSummary 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… | 2000 |
| * | K040005 | Profile 2000/3000 Laser SystemSummary 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… | 2004 |
| * | K010285 | Contour Profile LaserSummary 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… | 2001 |
What descends from it? (517)
See all 51710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K060033 | Profile Multi-Platform System | 2006 | 221 |
| K063571 | Palomar LUX2940 Handpiece | 2007 | 160 |
| K073572 | Matrix RF Applicator | 2008 | 102 |
| K072344 | Apl Medical System | 2007 | 6 |
| K052354 | Oculase MD | 2006 | 5 |
| K072182 | Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060 | 2008 | 3 |
| K051359 | Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory | 2005 | 1 |
| K082028 | Laserpeel Soft-Met Modified Erbium Laser | 2008 | 0 |
| K063427 | Lumina Intense Pulsed Light (& Laser) System | 2007 | 0 |
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 devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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.
https://510kreport.com/device/K042000 · printed Nov 6, 2026
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