(98 days)
The LipoEze Cannula is a suction hand piece intended for use with a 980nm laser fiberoptic delivery system during laser assisted lipolysis.
The LipoEze Cannula is a suction hand piece.
This document is a 510(k) premarket notification for the LipoEze Cannula, a medical device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on the administrative aspects of a 510(k) submission, confirming substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information.
§ 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.