# K122567: Joule 810/940/980 Multi-Platform System - Pathway: 510(k) (Traditional) - Applicant: Sciton, Inc - Decided: Jun 19, 2013 after 300 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: 19 generations back to K943450 (1995). 413 ancestors in all. 6 later devices descend from it; 3 cite it directly. 0 of 420 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application, Alma Lasers, Inc. (2011) Summary page 1. - K102036: Doctor Surgery Diode Lasers Family, Lambda S.P.A. (2010) Summary page 1. - K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 1. - K100143: Pilot Diode Laser, Model 002-00139, CAO Group, Inc. (2010) Summary page 1. - K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 1. ## Most influential descendants - K151890: Medical Diode Laser Systems (2015), 3 descendants of its own - K251077: JOULE 1064nm System and Accessories (2025), 0 descendants of its own - K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own - K191349: 980nm Diode Laser Therapy Device (2019), 0 descendants of its own - K173067: LightForce LTS Model 1000, 1500, 2500, and 4000 (2018), 0 descendants of its own ## Indications for use The JOULE 810/840/980 Multi-Platform System (and delivery accessaries used to deliver optical energy) is indicated for use in surgica) applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. The device is specifically indicated for use as follows: £10nm and 380nm Dermatology/Aesthetics: - Photocoagulation of vascular & dermatologicat lesions of the face and extremities - Photocoagulation of telangiectasia, veinutectasia of the legs and face - Treatment of reticular veins and branch varicosities - Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas - Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous takes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epiderma! pigment lesions as ientigines. Epidermal nevi, spider nevi. - Demmatological surgery: Condytoma acuminate, warts, small non malignant skon tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment. - Seborrheic keratosis - Mixoid cyst - Papillary varix - Acne treatment - Hair removal of unwanted hair from skin type |-V Plastic Surgery: - Cut, coagulation & vaporization - Resurfacing - Blepharoplasty Vascular Surgery: - Endoluminal or endovenous laser surgery for saphenous incompetent veins 810nm Temporary refief of minor muscie and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means ot topical elevated tissue temperature from infrared spectral emissions. The JOULE Multi-Piatform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telanglectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. it is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the long-temm, stable reduction in the number of hairs regrowing when measured at §, 9, and 12 months after the completion of a treatment regime. 240nm The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment {including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coaguiation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment andfor removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. 280nm The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in inciston, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted Gpolysis. The device is specifically indicated for use as follows! Dermatology, Plastic Surgery and Podiatry: Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include: - Matrixectomy - Excision of neuromas - Excision of periungual and subungual wars - Excision of plantar warts - Excision of keioids - Excision of cutaneous lesions - Dermabrasion - Vaporization and hemostasis of capillary hemangioma - Debridement of wounds - Photocoagutation of teleangectasia of the legs and face - Photocoagulation of vascular lesions of the face and extremities - Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux, - Treatment of reticular veins and branch varicosities Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux: Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. Source page: https://510kreport.com/device/K122567 Methodology: https://510kreport.com/methodology