(85 days)
Scanning Device Accessory for use with the CB Erbium / 2.94TM Er:YAG Laser for general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles.
The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.
The provided document, K971879, is a 510(k) summary for a "Scanning Device Accessory for the CB Erbium / 2.94TM Er:YAG Laser." This document states that no nonclinical or clinical performance data was provided or reviewed for this submission. Therefore, there is no information available to describe acceptance criteria or a study proving the device meets those criteria.
The submission concluded that the device "enhances the clinical application procedure while maintaining the performance characteristics" but this was based on comparison to an equivalent device (SoftScanTM Scanning Device, Sahar Technologies, Inc. K964684) and not on new performance data for the K971879 device itself.
Given the absence of performance data, all sections of your request regarding acceptance criteria and performance studies cannot be answered from this 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.