§ 884.4550. Gynecologic surgical laser.
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/us/cfr/t21/s§ 884.4550·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).