# K042000: Modified MSQ Family of Lovely Light/Laser Systems - Pathway: 510(k) (Traditional) - Applicant: Msq (M2), Ltd. - Decided: Dec 21, 2004 after 148 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 8 generations back to K910422 (1992). 153 ancestors in all. 517 later devices descend from it; 10 cite it directly. 0 of 671 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K033946: Lovely System, Msq (M2), Ltd. (2004) Summary page 1. - K021762: Bclear, Lumenis, Inc. (2002) Summary page 1. - K033251: The Friendlylight ND: Yag Lasers, Innotech USA, Inc. (2004) Summary page 1. - K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1. - K003460: Palomar Clear Light ND: Yag Laser System, Palomar Medical Technologies, Inc. (2001) Summary page 1. - K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 1. - K972347: Modified Coherent Versapulse Aesthetic Surgical Laser, Lumenis, Inc. (1997) Summary page 1. - K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1. - K022709: Medlite Q-Swithced Laser, Continuum Electro-Optics, Inc. (2003) Summary page 1. - K032459: Profile 1320 Laser System, Sciton, Inc (2004) Summary page 1. - K031184: Cool Touch 3, New Star Lasers, Inc. (2003) Summary page 1. - K031954: Cooltouch Incorporated MODELCT3 ND:Yag Surgical Laser Systems, New Star Lasers, Inc. (2003) Summary page 1. - K030453: Cooltouch ND: Yag Laser System, New Star Lasers, Inc. (2003) Summary page 1. - K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System, New Star Lasers, Inc. (2004) Summary page 1. - K033176: Tristar Aesthetic Workstation Laser, Cynosure, Inc. (2004) Summary page 1. - K974896: Laserscope EL Laser System and Accessories, Laserscope (1998) Summary page 1. - K971843: Laserscope Vela Erbium:Yag Laser System and Accessories, Laserscope (1997) Summary page 1. - K000023: Friendly Light ER:Yag Pulsed Laser, Innotech USA, Inc. (2000) Summary page 1. - K040005: Profile 2000/3000 Laser System, Sciton, Inc (2004) Summary page 1. - K010285: Contour Profile Laser, Sciton, Inc (2001) Summary page 1. ## Most influential descendants - K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own - K060033: Profile Multi-Platform System (2006), 221 descendants of its own - K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own - K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own - K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own ## Indications for use 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 Source page: https://510kreport.com/device/K042000 Methodology: https://510kreport.com/methodology