# K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models - Pathway: 510(k) (Traditional) - Applicant: Altus Medical, Inc. - Decided: Jun 3, 2002 after 178 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: 5 generations back to K910422 (1992). 35 ancestors in all. 739 later devices descend from it; 9 cite it directly. 0 of 775 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) Summary page 1. - K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (1998) Summary page 1. - K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1. - K980537: ND: Yag Accessory for Photoderm System, Esc Medical Systems, Ltd. (1998) Summary page 1. - K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 3. - K990718: Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (2000) Summary page 1. - K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1. - K941841: Smartscan, Laserscope (1994) Summary page 1. - K933880: SL Series Surgical Laser Systems, Laserscope (1994) Summary page 1. - K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration), Laserscope (2000) - K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1. - K010104: Candela Long Pulse ND:Yag, Candela Corp. (2001) Summary page 3. ## Most influential descendants - K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own - K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own - K023193: Candela Gentle Yag Laser System (2002), 656 descendants of its own - K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own - K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own ## Indications for use The family of Modified Altus Medical CoolGlide Aesthetic Lasers 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 Modified CoolGlide laser systems are intended for the coaguiation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented €esionssuch 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 Modified 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 pseudofolliculitisbarbae (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 Modified 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 Modified 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. Surgical Applications:: The lasers are indicated for the incisiodexcision and cutting, ablation, coagulatiodhemostatis 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/thoracicsurgery, 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; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). Source page: https://510kreport.com/device/K014040 Methodology: https://510kreport.com/methodology