(91 days)
The MedLite™ C1 Q-Switched Nd:YAG Laser is intended for: Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Not Found
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the MedLite™ C1 Q-Switched Nd:YAG Laser, which focuses on demonstrating substantial equivalence to a predicate device rather than providing performance data against specific acceptance criteria.
The "Nonclinical Performance Data" and "Clinical Performance Data" sections both state "None," indicating that no specific performance studies were included in this submission to prove device performance against acceptance criteria.
Therefore, I cannot extract the requested information from 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.