# K072564: Alma Lasers Harmony XL Multi-Application Platform

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: May 23, 2008 after 255 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: 14 generations back to K943450 (1995). 238 ancestors in all.
266 later devices descend from it; 20 cite it directly.
0 of 505 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.
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004)
- K051428: Vtrac Excimer Lamp System, Photo Medex, Inc. (2005) Summary page 1.
- K060448: Lumenis One Family of Systems; Lumenis One., Lumenis, Ltd. (2006) Summary page 1.
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems, Lumenis, Ltd. (2003) Summary page 1.
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems, Lumenis, Ltd. (2003) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.
- K050679: Cutera Solera Opus Aesthetic Product, Cutera, Inc. (2005) Summary page 1.
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 1.
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 1.
- K030186: Polris LV, Syneron Medical, Ltd. (2003) Summary page 1.
- K052324: Polaris LV, Lva Applicator, Syneron Medical, Ltd. (2005) Summary page 1.
- K042630: Revlight Skin Care System, Skincare Technology, Inc. (2005) Summary page 1.
- K982546: Phaser-2000, Diomedics, Inc. (1998) Summary page 2.
- K041879: Palomar LUX1064 Handpiece, Palomar Medical Technologies, Inc. (2005) Summary page 2.
- K043429: Cynergy Laser, Cynosure, Inc. (2005) Summary page 2.
- K033176: Tristar Aesthetic Workstation Laser, Cynosure, Inc. (2004) Summary page 2.
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 2.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 2.

## Most influential descendants
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor (2010), 92 descendants of its own
- K121346: Picosure Workstation (2012), 87 descendants of its own
- K142372: Pico Way Laser System (2014), 70 descendants of its own

## Indications for use
The Harmony XLTM Multi-Application Platform is 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 Harmony XLTM Multi-Application Platform: 300-380 nm UVB Module Handoiece The 300-380 nm UVB module handpiece 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. 420-950 nm Acne Module AFT Handpiece The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module handpiece (with and without contact-cooling) is indicated for: * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions including dyschromia, 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. * Use on all skin types (Fitzpatrick I-VI). 515-950 nm SV515 & SVL515 Module AFT Handpieces The Advanced Fluorescence Technology (AFT) 515-950 nm VL515 and SVL515 Module handpieces (with and without contact-cooling) are indicated for: * The treatment of moderate inflammatory acne (acne vulgaris). * The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and café-au-lait macules. * 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 to effect stable long-term or permanent hair reduction. * Use on Fitzpatrick skin types I-V. 540-950 nm VL/PL, VP, and SSR Module AFT Handpieces The Advanced Fluorescence Technology (AFT) 540-950 nm VL/PL, VP, and SSR Module handpieces (with and without contact-cooling) are indicated for: * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and café-au-lait macules. * 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 to effect stable long-term or permanent hair reduction. * Use on all skin types (Fitzpatrick I-VI). 570-950 nm SR Module AFT Handpiece The Advanced Fluorescence Technology (AFT) 570-950 nm SR Module handpiece (with and without contact-cooling) is indicated for: * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). * The treatment of face and body vascular and pigmented lesions. * The treatment of cutaneous lesions, including scars and striae. * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * The removal of unwanted hair to effect stable long-term or permanent hair reduction. * Use on all skin types (Fitzpatrick I-VI). 590 nm LED Module Handpiece The 590 nm LED module handpiece is indicated to: * Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain. * Provide topical heating for the purpose of elevating and/or maintaining tissue temperature. 650-950 nm HR Module AFT Handpiece The Advanced Fluorescence Technology (AFT) 650-950 nm HR Module handpiece (with and without contact-cooling) is indicated for: * The treatment of tattoos. * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and café-au-lait. * 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. * Use on all skin types (Fitzpatrick I-VI), including tanned skin. 780-950 nm SHR and ST AFT Module Handpieces The Advanced Fluorescence Technology (AFT) 780-950 nm SHR and ST Module handpieces (with and without contact-cooling) are indicated for: * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions including dyschromia, 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 treatment of pseudofolliculitis barbae (PFB). * The removal of unwanted hair and to effect stable long-term or permanent hair reduction. * Use on all skin types (Fitzpatrick I-VI), including tanned skin. 780-950 nm SST AFT Module Handpiece The Advanced Fluorescence Technology (AFT) 780-950 nm SST Module handpiece (with contact-cooling) is indicated for: * The treatment of tattoos. * The treatment of moderate inflammatory acne vulgaris. * The treatment of benign pigmented epidermal lesions including dyschromia, 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 treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis. * The treatment of pseudofolliculitis barbae (PFB). * The removal of unwanted hair to effect stable long-term or permanent hair reduction. * Use on all skin types (Fitzpatrick I-VI), including tanned skin. 1064 nm Long Pulsed and Q-Switched Nd:YAG Laser Module Handpieces The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) 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 dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas. * Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis. 1064 nm Long Pulsed and Q-Switched Nd:YAG Laser Module Handpieces - continued The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched, with and without contact-cooling) - continued: Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Café-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. 1064 nm Long Pulsed and Q-Switched Nd:YAG Laser Module Handpieces - continued The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched, with and without contact-cooling) - 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. * 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 I-VI), including tanned skin. 1064 nm Long Pulsed Only Nd:YAG Laser Module Handpieces The 1064 nm Nd:YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for: * 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) * Treatment of pseudofolliculitis barbae (PFB) 532 nm Long Pulsed and Q-Switched FD Nd:YAG Laser Module Handpiece Tips The 532 nm Frequency-Doubled (FD) Nd:YAG Laser Module handpieces tips (Long Pulsed and Q-Switched, with and without contact-cooling) are indicated for: * Incision, excision, ablation, vaporization of soft tissue. * Tattoo removal: Light blue; Yellow; Red; Green. * Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi. 532 nm Long Pulsed and Q-Switched FD Nd:YAG Laser Module Handpiece Tips - continued The 532 nm Frequency-Doubled (FD) Nd:YAG Laser Module handpiece tips (Long Pulsed and Q-Switched, with and without contact-cooling) are indicated for: * Benign pigmented lesions: Café-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. 1320 nm Nd:YAG Laser Module Handpiece 1320 nm Nd:YAG Laser Module handpiece (with and without contact-cooling) 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 2940 nm Er:YAG Laser Module Handpiece with Standard & Scanner Accessory Tips The 2940 nm Er:YAG Laser Module handpiece with standard and scanner accessory tips (with and without contact-cooling) 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: DERMATOLOGY AND PLASTIC SURGERY: * 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 tumors * Debulking cysts * Superficial skin lesions * Diagnostic biopsies * Decubitus ulcers 2940 nm Er:YAG Laser Module Handpiece with Standard & Scanner Accessory Tips - 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, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar lesions, polyps, and familiar polyps of the colon. GYNECOLOGY: Treatment of: * Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. 2940 nm Er:YAG Laser Module Handpiece with Standard & Scanner Accessory Tips - Continued ORAL/MAXILLOFACIAL: Treatment of: * Benign oral tumors, oral and glossal lesions, and gingivectomy. OTORHYNOLARINGOLOGY/HEAD AND NECK (ENT): Treatment of: * Ear, nose and throat lesions, polyps, cysts, hyperkeratosis. * Excision of carcinogenic tissue and oral leukoplakia. OPHTHALMOLOGY: Treatment of: * Soft tissue surrounding the eye and orbit. PODIATRY: Treatment of: * Warts, plantar verrucae, large mosaic verrucae. * Matrixectomy. 2940 nm Er:YAG Laser Module Handpiece with Pixel Accessory Tips The 2940 nm Er:YAG Laser Module handpiece (with and without contact-cooling) with Pixel accessory tips is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: * Skin resurfacing Thermoelectric Cooler (TEC) The thermoelectric cooler, integrated into the light and laser handpieces, is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: * Reduce pain during and/or associated with light or laser treatment; * Reduce discomfort during and/or associated with light or laser treatment; * Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; * Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and * Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Source page: https://510kreport.com/device/K072564
Methodology: https://510kreport.com/methodology