← Product Code [HEX](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX) · K902313

# LM-1Z ZOOM SCOPE (K902313)

_Leisegang Medical, Inc. · HEX · Sep 4, 1990 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K902313

## Device Facts

- **Applicant:** Leisegang Medical, Inc.
- **Product Code:** [HEX](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX.md)
- **Decision Date:** Sep 4, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1630
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K902313](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K902313)

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