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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 884 - Obstetrical and Gynecological Devices |
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Subpart E - Obstetrical and Gynecological Surgical Devices |
§ 884.4550 - Gynecologic surgical laser.
Latest version.
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§ 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).