# K070805: Ultrawave II EX 1320 - Pathway: 510(k) (Traditional) - Applicant: Quanta System Spa - Decided: Jul 11, 2007 after 110 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 150 later devices descend from it; 4 cite it directly. 0 of 151 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) Adept Medical Concept's Adept 1064/755 Laser: named in the summary without a submission number - (no number) Sciton, Inc.'s Profile 1320 Laser: named in the summary without a submission number - (no number) Altus Medical Inc.'s Altus Medical Coolidge Laser Systems and Accessories: named in the summary without a submission number - (no number) Quanta System's Eterna Giovinezza System: named in the summary without a submission number - (no number) Cynosure's YAG Family of Lasers: named in the summary without a submission number - (no number) Cynosure Apogee Elite laser: named in the summary without a submission number ## Most influential descendants - K081352: Profile Multi-Platform System (2008), 112 descendants of its own - K101916: Joule Multi-Platform System (2011), 111 descendants of its own - K083207: Ultrawave Iii EX 1320 (2008), 96 descendants of its own - K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own - K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own ## Recalls of this device - Nov 7, 2012 · Class II · Z-0693-2013: Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made ther ## Indications for use Nd:YAG 1064nm Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics. General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. It addition, the laser is 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 blue and/or black tattoos), and plaques. The ULTRAWAVE II EX 1320 laser is also 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 ULTRAWAVE H1 EX 1320 laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The ULTRA4WAVE H EX 1320 is 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 of pseudofolliculitis barbae (PFB). The ULTRAWAVE II EX 1320 is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The ULTRAWAVE II EX 1320 is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obtructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminate). Nd:YAG 1320nm Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars. Alexandrite 755nm Intended for coagulation and hemostatis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles. /PL 590-1200nm: 625-1200nm; 650-1200nm Indicated for permanent hair reduction. 550-1200nm; 570-1200nm Indicated for photocoagulation of dermatological vascular lesion ( i.e.,face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. 400-1200nm Indicated for inflammatory acne (acne vulgaris). Integrated Skin Cooler The intended use of the integrated cooling system in the ULTRAWAVE II EX 1320 hand piece 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 fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incoimect. Source page: https://510kreport.com/device/K070805 Methodology: https://510kreport.com/methodology