(90 days)
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles.
The PhotoGenica VL is a pulse-dye laser, having the organic dye as the lasing medium. It is a pulsed laser with a wavelength of 580 to 590nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The provided text is a 510(k) Summary for the PhotoGenica VL Medical Laser System. This document explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
Therefore, there is no information available within this document to describe acceptance criteria or a study that proves the device meets any such criteria. The device's substantial equivalence was based on its similarity to a predicate device (NLite Laser by ICN Pharmaceuticals, Inc.) regarding its indication for uses, principle of operation, wavelength, and pulse energy range, rather than performance studies demonstrating effectiveness against specific criteria.
§ 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.