(53 days)
The device is intended for use with an appropriate laser for vein ablation procedures.
The ELAtionTM Endovenous Laser Procedure Kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein and for treatment of incompetence and reflux of superficial veins in the lower extremity. The kit is intended to be used with an 810 nm, 940 nm, or 980 nm laser.
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I cannot answer your request the text that you provided is a 510k summary, not a study.
§ 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.