---
kind: "section"
citation: "21 C.F.R. § 884.1630"
title: "21"
number: "884.1630"
heading: "Colposcope."
url: "https://uscodex.org/cfr/21/884.1630"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

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