Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1630](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1630) → PTZ — Colposcope (And Colpomicroscope), Exempt

# PTZ · Colposcope (And Colpomicroscope), Exempt

_Obstetrics/Gynecology · 21 CFR 884.1630 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PTZ

## Overview

- **Product Code:** PTZ
- **Device Name:** Colposcope (And Colpomicroscope), Exempt
- **Regulation:** [21 CFR 884.1630](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1630)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

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.

## Special Controls

*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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PTZ](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PTZ)

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