(210 days)
The Laser Aesthetics COOLTOUCH "V" Nd:YAG laser is indicated for use in surgical procedures for the coagulation and hemostasis of vascular lesions and soft tissue.
The Laser Aesthetics COOLTOUCH "V" Nd:YAG Surgical Laser is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics and the handpiece.
The provided document is a 510(k) summary for the COOLTOUCH "V" Nd:YAG Surgical Laser. It explicitly states in the "Nonclinical Performance Data" and "Clinical Performance Data" sections that "None" were provided.
Therefore, the device does not have any reported acceptance criteria or a study proving it meets them within this submission. The 510(k) approval is based on substantial equivalence to predicate devices, not on direct performance data from a specific study outlined here.
Consequently, I cannot provide the requested information as it is not present in the provided text.
§ 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.