# K120235: Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp - Pathway: 510(k) (Traditional) - Applicant: Aerolase Medical Lasers, LLC - Decided: Sep 17, 2012 after 236 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: 12 generations back to K943450 (1995). 192 ancestors in all. 33 later devices descend from it; 1 cites it directly. 0 of 226 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K033251: The Friendlylight ND: Yag Lasers, Innotech USA, Inc. (2004) Summary page 1. - K103626: Cutera Genesisplus Laser System, Cutera, Inc. (2011) Summary page 1. - K093545: Pinpointe Footlaser Model 6W, 30W, 100W, Incisive, Inc. (Formerly Named Incisive, LLC) (2010) Summary page 1. - K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 1. - K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,, Fotona D.D. (2009) Summary page 1. - K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A, Fotona D.D. (2011) Summary page 1. ## Most influential descendants - K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own - K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own - K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own - K222064: The Alma Soprano Titanium (2022), 14 descendants of its own - K183156: V-Laser (2019), 3 descendants of its own ## Indications for use The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endloscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications. Dermatology: The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikilodlerma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, debridement of dlecubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe§ au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the Aerolase Nd:YAG Laser is indicated for 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 Aerolase Nd:YAG Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris. The Aerolase Nd:YAG Laser is also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. Podiatry: Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including: Matrixectomy; Periungual and subungual warts; Plantar warts; Radical nail excision; Neuromas. General Surgery: The Aerolase Nd:YAG Laser is indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery; pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Source page: https://510kreport.com/device/K120235 Methodology: https://510kreport.com/methodology