(78 days)
The LaserLite diode surgical laser is indicated for incision, excision, vaporization, ablation, cutting, hemostasis and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
The LaserLite diode surgical laser is a semiconductor diode laser operating at 810 + 20 microns.
The provided 510(k) summary for the LaserLite Diode Surgical Laser explicitly states "Performance data: None." It explains that because the specifications and indications for use are "the same or very similar" to legally marketed predicate devices (e.g., Diomed Diode 60W laser K962354), and it has no additional indications for use, performance data was not required.
Therefore, there is no information in the provided document about acceptance criteria or a study proving the device meets them. This submission relies on substantial equivalence to predicate devices rather than 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.