(183 days)
The Smart File laser device is to provide the ability to perform intraoral soft tissue, general, and oral maxillo-facial surgery. The device is intended for ablation, incision, vaporization and coagulation of soft tissue using a contact, fiber optic delivery system. The device will be used in the folowing areas: general dentistry, otolaryngology, dermatology and plastic surgery.
Smart File is a Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm. Laser activation is by footswitch. Overall weight of the laser is 38 Kg, and the size is 68x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
The provided text is a 510(k) Summary for the Cynosure Smart File, Smart File 6, and Smarty A10 medical laser systems. It explicitly states in the "Nonclinical Performance Data" and "Clinical Performance Data" sections that there is "none".
Therefore, no acceptance criteria, study details, sample sizes, expert qualifications, or ground truth information related to device performance are present in the provided document. The device was found substantially equivalent based on its comparison to predicate devices in terms of indications for use, principle of operation, wavelength, and pulse energy range, rather than through clinical or nonclinical performance studies detailed in this summary.
§ 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.