# K060448: Lumenis One Family of Systems; Lumenis One. - Pathway: 510(k) (Traditional) - Applicant: Lumenis, Ltd. - Decided: Jul 6, 2006 after 135 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: 13 generations back to K943450 (1995). 120 ancestors in all. 297 later devices descend from it; 5 cite it directly. 0 of 418 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) 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 3. - K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems, Lumenis, Ltd. (2003) Summary page 3. - K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems, Lumenis (2003) Summary page 1. - K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 3. - K974346: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1998) Summary page 3. - K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 1. - K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products), Coherent Star (2000) Summary page 3. - K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 3. - K051214: Aluma Skin Renewal System, Lumenis, Inc. (2005) Summary page 3. ## Most influential descendants - K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own - 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 ## Indications for use The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows: Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm): The 515-1200 nm intense pulsed light wavelengths are indicated for: * The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * The treatment of tattoos; * 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 from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Nd:YAG Laser Wavelength (1064 nm): The 1064 nm wavelength produced by the Nd:YAG laser is indicated for: * The 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 removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles; * The non-ablative treatment of facial wrinkles. LightSheer Diode Laser Wavelength (800 nm): The 800 nm wavelength produced by the LightSheer diode laser is indicated for: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles; * The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions; The treatment of leg veins; The treatment of benign pigmented lesion; The treatment of pseudofolliculitis barbae; The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. Aluma RF Energy (468 kHz): The Aluma 468 kHz energy is indicated for: The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and rhytids. Source page: https://510kreport.com/device/K060448 Methodology: https://510kreport.com/methodology