# K023954: Altus Medical Coolglide Laser Systems and Accessories - Pathway: 510(k) (Traditional) - Applicant: Altus Medical, Inc. - Decided: Mar 18, 2003 after 111 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). 28 ancestors in all. 1,117 later devices descend from it; 19 cite it directly. 0 of 1,146 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos, Medical Bio Care Sweden AB (2002) - K000929: Prolite Pulsed Light System, Medical Bio Care Sweden AB (2000) Summary page 1. - K002072: Prolite VL Pulsed Light System, Medical Bio Care Sweden AB (2000) Summary page 1. - K010927: Modification to Prolite Pulsed Light System, Medical Bio Care Sweden AB (2001) Summary page 1. - K010928: Prolite VL Pulsed Light System, Medical Bio Care Sweden AB (2001) Summary page 1. - K013366: Prolite Pulsed Light System for the Removal of Unwanted Hair, Medical Bio Care Sweden AB (2002) - K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair, Medical Bio Care Sweden AB (2002) Summary page 1. - K022569: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular Lesions, Medical Bio Care Sweden AB (2002) Summary page 1. - K960772: Photoderm PL., Esc Medical Systems, Ltd. (1996) Summary page 1. - K963249: Epilight Hair Removal System, Esc Medical Systems, Ltd. (1997) Summary page 1. - K974536: Photoderm HR System, Esc Medical Systems, Ltd. (1998). Our reading of the summary gave K374536, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. - K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1. - K994014: Esc Intense Pulsed Light Systems: Epilight and Multilight, Esc Medical Systems, Ltd. (2000) Summary page 1. - K020941: Palomar Luxg Handpiece, Palomar (2002) ## Cited in the summary but kept off the family tree - K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001). Our reading of the summary gave K012130, FDA’s number for Attain LDS 6216 Left-Heart Delivery System (Medtronic Vascular). Its FDA name has none of the distinctive words the summary uses for the device it names, “Prolite/Plasmalite”. Kept off the family tree. - K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K033946: Lovely System (2004), 737 descendants of its own - K031671: Polaris WR (2003), 678 descendants of its own - K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own - K032460: Profile BBL System (2003), 569 descendants of its own - K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own ## Indications for use The family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece: are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic 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, keraioses, 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 the 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 optional pulsed light hand piece is indicated for the treatment of benign pigmented lesions. The intended use of the integral cooling system in the Altus CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment, 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. Optional Pulsed Light Hand Piece: For the treatment of benign pigmented lesions. Surgical Applications: The lasers are indicated for the incisiodexcision and cutting, ablation, coagulationhemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology. 532nm: For c.oagulation 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, cafe-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/K023954 Methodology: https://510kreport.com/methodology