(110 days)
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, ven us 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 II 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 ULTRAWAVE II 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.
IPL:
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 incorrect.
The ULTRAWAVE II FX 1320 consists of two laser sources and an IPL. The laser sources emit wavelengths of 1064nm,1320nm for the Nd:YAG source and 755nm for the Alexandrite source. The IPL has several different ULTRAWAVE II FX 1320 includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; an integral skin cooler; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
The provided document is a 510(k) summary for the ULTRAWAVE II EX 1320 device, which is a laser surgical instrument. It outlines the device's intended use, technological characteristics, and a comparison to predicate devices for substantial equivalence.
Critically, the document explicitly states under "Performance Data": "None."
This single statement means that the information requested for acceptance criteria and the study proving the device meets those criteria is not present in the provided text. The submission relies on demonstrating "substantial equivalence" to existing predicate devices, rather than submitting new clinical or performance data for the ULTRAWAVE II EX 1320 itself.
Therefore, I cannot provide the requested table and details because the submission states it did not include performance data. The device's approval was based on its similarity to previously approved devices, implying that their performance and safety profiles are considered equivalent.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.