# K033946: Lovely System

- Pathway: 510(k) (Traditional)
- Applicant: Msq (M2), Ltd.
- Decided: Apr 5, 2004 after 108 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910422 (1992). 85 ancestors in all.
737 later devices descend from it; 9 cite it directly.
0 of 823 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems, Lumenis, Ltd. (2003) Summary page 4.
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems, Lumenis (2003) Summary page 4.
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems, Lumenis, Ltd. (2003) Summary page 4.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 4.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 4.
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 4.
- K030338: Iclear Phototherapy System, Model FGCM0002, Curelight, Ltd. (2003) Summary page 6.
- K020591: Bclear, Lumenis (2002) Summary page 4.
- K021762: Bclear, Lumenis, Inc. (2002) Summary page 6.
- K970808: Medlite IV Q-Switched, Frequency Doubled, ND:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 5.
- K973719: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 5.
- K983054: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser, Continuum Biomedical, Inc. (1999) Summary page 5.
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001)
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 5.
- K022709: Medlite Q-Swithced Laser, Continuum Electro-Optics, Inc. (2003) Summary page 5.

## Most influential descendants
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K041969: Aurora DS (2004), 302 descendants of its own
- K050796: Aurora DS, DS Applicator (2005), 301 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033946
Methodology: https://510kreport.com/methodology