21 C.F.R. § 884.1630

Current through October 31, 2024
Section 884.1630 - Colposcope
(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 .

21 C.F.R. §884.1630

45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816 , Dec. 30, 2019