# K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models - Pathway: 510(k) (Traditional) - Applicant: Altus Medical, Inc. - Decided: Oct 8, 2002 after 90 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: 6 generations back to K910422 (1992). 77 ancestors in all. 665 later devices descend from it; 11 cite it directly. 0 of 743 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K991798: Acme Medical Aesthetic ND:Yag Laser, Altus Medical (2000) Summary page 1. - K991234: The Acme Medical Aesthetic ND:Yag Laser, Acme Medical, Inc. (1999) Summary page 1. - K003202: Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II, Altus Medical (2001) - K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models, Altus Medical, Inc. (2002) - K000811: Nlite System, SLS Model Number A00-1025, Sls Biophile, Ltd. (2000) Summary page 3. - K014130: Nlite System, Icn Photonics, Ltd. (2002) Summary page 4. - K013461: Nlite System,Model A00-1025, Icn Photonics, Ltd. (2002) Summary page 4. - K013043: Candela Clearbeam Pulsed Dye Laser, Candela Corp. (2001) - K013748: Candela Sclero Long Pulse Laser (Aka Vbeam), Candela Corp. (2002) Summary page 4. - K012806: Cynosure Photogenica VL, Cynosure, Inc. (2001) Summary page 4. - K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems, Cooltouch Corp. (2002) - K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II, Cooltouch Corp. (2001) Summary page 1. - K013825: Candela Smoothbeam Laser System, Candela Corp. (2002) - K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1. ## Most influential descendants - K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own - K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own - K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own - K023881: Profile 1064 Laser System (2003), 227 descendants of its own - K060033: Profile Multi-Platform System (2006), 221 descendants of its own ## Indications for use The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopicAaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonaryhhoracic surgery and urology for surgical and aesthetic applications. 1064nm: Dermatology: The Altus Medical Aesthetic CoolGlide laser systems are 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 poikiloderma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafk au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blueblack tattoos) and plaques. Additionally, the lasers are 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 CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The CoolGlide lasers are 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). The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The intended use of the integral cooling system in the Altus CoolGlide laser handpiece is to provide cooling of the skin, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. Surgical Applications: The lasers are indicated for the incisiodexcision and cutting, ablation, coagulationhemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, head and necldotorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology. 532nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; slun tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). Source page: https://510kreport.com/device/K022226 Methodology: https://510kreport.com/methodology