21 C.F.R. § 884.4550

Current through September 30, 2024
Section 884.4550 - Gynecologic surgical laser
(a)Identification. A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.
(b)Classification. Class II (performance standards).

21 C.F.R. §884.4550