(84 days)
The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 - 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.
Not Found
This document is a 510(k) summary for the Surgical Lightstic™ 180, a laser fiber device. It demonstrates substantial equivalence to predicate devices. The document explicitly states: "Performance Data: None required."
Therefore, based on the provided text, there is no acceptance criteria or study described proving the device meets acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices, which means it asserts that its technological characteristics and intended use are similar enough to already legally marketed devices that it does not raise new questions of safety or effectiveness.
§ 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.