§ 884.1630. Colposcope.
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/us/cfr/t21/s§ 884.1630·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.
(b)Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]