510(k) · Cleared
ClearedLovely System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Msq (M2), Ltd. · FTC Light, Ultraviolet, Dermatological
Cleared on Apr 5, 2004 as substantially equivalent to K030342 (Lumenis, Ltd., 2003) and 14 other predicates after a 108-day review. Its family tree reaches back 7 generations to 1992. 737 later devices descend from it.
- Decided
- Apr 5, 2004
- Review
- 108 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 7 generations to K910422 (1992). 85 ancestors in all, the oldest K885026 (1989). 737 later devices descend from it, 9 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 2 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 1 generation backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- This deviceK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · cites it directly · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004
- Descendant · 2 generations on · 301 of its ownK050796 Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005
- Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
Showing 5 of 737 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 737 · See all- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
- K041969Aurora DSSyneron Medical, Ltd. · 2004 · cites it directly302descendants
- K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005 · 2 generations on301descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −1 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| 0 (this device) | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +1 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +1 | K041969 | Aurora DS | Syneron Medical, Ltd. | 2004 | — |
| +2 | K050796 | Aurora DS, DS Applicator | Syneron Medical, Ltd. | 2005 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 23 | 0 |
| 2009 | 12 | 0 |
| 2010 | 17 | 0 |
| 2011 | 17 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 35 | 0 |
| 2017 | 33 | 0 |
| 2018 | 32 | 0 |
| 2019 | 23 | 0 |
| 2020 | 43 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 47 | 0 |
| 2024 | 82 | 0 |
| 2025 | 105 | 0 |
| 2026 | 65 | 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 FTC? 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 FTC device
- #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (15)
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 |
|---|---|---|---|
| * | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsSummary page 4…umnenis Family of Intense Pulse-Light (IPL) and IPL/ND:YAG Laser Systems ("Lumenis Combined IPL") cleared under K030342, K030527and K024093. * EstelUXTM (Palomar Medical Technologies) cleared under… | 2003 |
| * | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsSummary page 4…amily of Intense Pulse-Light (IPL) and IPL/ND:YAG Laser Systems ("Lumenis Combined IPL") cleared under K030342, K030527and K024093. * EstelUXTM (Palomar Medical Technologies) cleared under K0204… | 2003 |
| * | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Summary page 4…tense Pulse-Light (IPL) and IPL/ND:YAG Laser Systems ("Lumenis Combined IPL") cleared under K030342, K030527and K024093. * EstelUXTM (Palomar Medical Technologies) cleared under K020453.… | 2003 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 4…cleared under K030342, K030527and K024093. * EstelUXTM (Palomar Medical Technologies) cleared under K020453. • Altus Medical Family of Altus Medical CoolGlide Aesthetic Lasers with O… | 2002 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 4…ily of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulse Light Handpiece ("CoolGlide") cleared under K023954. • ClearLigaht Phototherapy Device, Model CL-420 ("Clearl-ig… | 2003 |
| * | K013623 | Clearlight Phototheraphy System, Model CL 420Summary page 4…3954. • ClearLigaht Phototherapy Device, Model CL-420 ("Clearl-ight") (CureL-ight Ltd) cleared under K013623 and K03033S. * Bclear TNl (Lumenis, Inc.) cleared under K020591 and… | 2002 |
| * | K030338 | Iclear Phototherapy System, Model FGCM0002Summary page 6…• ClearLight Phototherapy Device, Model CL420 t"ClearLight") (CureLight Ltd) cleared under K013623 and K030338. · BclearTM l (Lumenis, Inc.) cleared under K020591 and K021762.… | 2003 |
| * | K020591 | BclearSummary page 4…("Clearl-ight") (CureL-ight Ltd) cleared under K013623 and K03033S. * Bclear TNl (Lumenis, Inc.) cleared under K020591 and KO021762. 10-3… | 2002 |
| * | K021762 | BclearSummary page 6…d under K013623 and K030338. · BclearTM l (Lumenis, Inc.) cleared under K020591 and K021762. 10-5 Medlite Q-Switched Laser ("Medlite") (Continuum Electro- Opti… | 2002 |
| * | K970808 | Medlite IV Q-Switched, Frequency Doubled, ND:Yag LaserSummary page 5…10-3 · Medlite Q-Switched Laser ("Medlite") (Continuum Electro- Optics, Inc.) cleared under K970808, K973719, K983054, KO1 1677, K014234 and K022709. Performance Standards: The Lovely… | 1997 |
| * | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserSummary page 5…10-3 · Medlite Q-Switched Laser ("Medlite") (Continuum Electro- Optics, Inc.) cleared under K970808, K973719, K983054, KO1 1677, K014234 and K022709. Performance Standards: The Lovely Diode La… | 1997 |
| * | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserSummary page 5…= Page 5 === · Medlite Q-Switched Laser ("Medlite") (Continuum Electro- Optics, Inc.) cleared under K970808, K973719, K983054, KO1 1677, K014234 and K022709. Performance Standards: The Lovely Diode Laser compl… | 1999 |
| * | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser | 2001 |
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary page 5…ite Q-Switched Laser ("Medlite") (Continuum Electro- Optics, Inc.) cleared under K970808, K973719, K983054, KO1 1677, K014234 and K022709. Performance Standards: The Lovely Diode Laser complies with:U.S. Federal Perf… | 2002 |
| * | K022709 | Medlite Q-Swithced LaserSummary page 5…ed Laser ("Medlite") (Continuum Electro- Optics, Inc.) cleared under K970808, K973719, K983054, KO1 1677, K014234 and K022709. Performance Standards: The Lovely Diode Laser complies with:U.S. Federal Performance Stan… | 2003 |
What descends from it? (737)
See all 7379 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042000 | Modified MSQ Family of Lovely Light/Laser Systems | 2004 | 517 |
| K042630 | Revlight Skin Care System | 2005 | 402 |
| K041969 | Aurora DS | 2004 | 302 |
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K063249 | Beamax | 2007 | 58 |
| K053324 | Chromolite System | 2006 | 31 |
| K081408 | Ellipse Multiflex | 2008 | 7 |
| K072344 | Apl Medical System | 2007 | 6 |
| 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 1.1 years on median.
- 2 of the 85 ancestors have a recall of any class.
- Of its descendants, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 descendants of its own.
- 5 other devices also cite its predicate K030342.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, 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 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
What is it indicated for?
The Lovely System models (Aria and Harmony) are intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of plastic surgery and dermatology as follows: Lovely I (Aria) & Lovely II (Harmony) Models: The Advanced Fluorescence Technology (AFT) with 420-950 nm wavelengths is indicated for: • The treatment of moderate inflammatory…
Read the full statement (245 words)
The Lovely System models (Aria and Harmony) are intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of plastic surgery and dermatology as follows:
Lovely I (Aria) & Lovely II (Harmony) Models:
The Advanced Fluorescence Technology (AFT) with 420-950 nm wavelengths is indicated for:
• The treatment of moderate inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, 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.
Lovely I (Harmony) Model:
The Nd:YAG lasers (1064nm) are indicated for:
• The removal of black, blue or green tattoos.
• Coagulation and hemostasis of vascular lesions and soft tissue, including treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins 0.1-4.0 mm diameter) of the leg,
• The non-ablative treatment of facial wrinkles.
Lovely II (Harmony) Model:
The UVB Light source (300-380nm) is indicated for:
• The treatment of leukoderma, including vitiligo (acquired leukoderma).
• The treatment of psoriasis, atopic dermatitis (eczema), and seborrheic dermatitis.
The Lovely System models are also indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033946: Lovely System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033946
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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