# K023881: Profile 1064 Laser System - Pathway: 510(k) (Traditional) - Applicant: Sciton, Inc - Decided: Jun 13, 2003 after 204 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: 7 generations back to K910422 (1992). 83 ancestors in all. 227 later devices descend from it; 5 cite it directly. 0 of 311 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K002853: Sciton Image Hair Removal Laser, Sciton, Inc (2000) Summary page 1. - K003046: Image Vascular Laser, Sciton, Inc (2000) - K010285: Contour Profile Laser, Sciton, Inc (2001) Summary page 3. - K991234: The Acme Medical Aesthetic ND:Yag Laser, Acme Medical, Inc. (1999) Summary page 1. - K991798: Acme Medical Aesthetic ND:Yag Laser, Altus Medical (2000) 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) - K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1. - 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. - K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration), Laserscope (2000) Summary page 1. - K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1. - K010284: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1. - K010834: Lyra Series Surgical Laser System & Accessories, Laserscope (2001) - K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1. - K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (1998) Summary page 1. ## Most influential descendants - K060033: Profile Multi-Platform System (2006), 221 descendants of its own - K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own - K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own - K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own - K070388: Profile Multi-Platform System (2007), 129 descendants of its own ## Indications for use The Profile 1064 Laser Systems and Accessories 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. Dermatology: Coagulation 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 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 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 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 Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and 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: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology. Source page: https://510kreport.com/device/K023881 Methodology: https://510kreport.com/methodology