(23 days)
• Tattoo Removal
• Treatment of Vascular Lesions
• Treatment of Pigmented Lesions
• Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
The MedliteTM C3 Q-Switched Nd:YAG Laser bases its design/construction from the integration of primary subsystems extracted from legally marketed predicate Continuum products. The new device performs and is specified within all product parameters of the predicate devices.
The provided 510(k) summary for the Medlite™ C3 Q-Switched Nd:YAG Laser explicitly states "None" for both "Nonclinical Performance Data" and "Clinical Performance Data".
Therefore, no information is available within this document to answer the requested questions regarding acceptance criteria and a study demonstrating the device meets those criteria. The device was found substantially equivalent to predicate devices based on its design/construction and performance within product parameters of those predicates, not on new performance data.
§ 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.