(247 days)
The Quanta System Eterna Giovinezza system is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. It is also indicated for treatment of inflammatory acne (acne vulgaris) and cutaneous lesions, including warts, scars, and striae.
The Quanta System Eterna Giovinezza system is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications Light emission activation is by foot switch. Overall weight of the system is 110 lbs., and the size is 13.8" x 19" x 40" (LxWxH). Electrical requirement is 110 VAC, 15A, 50 Hz, single phase.
The provided text is a 510(k) summary for the Quanta System Eterna Giovinezza system. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary explicitly states under "Nonclinical Performance Data" and "Clinical Performance Data": "none". This indicates that no studies demonstrating performance against specific criteria were submitted as part of this premarket notification.
Therefore, I cannot provide the requested information, as it is not present in the provided document.
§ 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.