Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart E - Obstetrical and Gynecological Surgical Devices / § 884.4550 Gynecologic surgical laser.
§ 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).