COLPOSCOPES AND ACCESSORIES
Device Facts
| Record ID | K940094 |
|---|---|
| Device Name | COLPOSCOPES AND ACCESSORIES |
| Applicant | Leisegang Medical, Inc. |
| Product Code | HEX · Obstetrics/Gynecology |
| Decision Date | Apr 25, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1630 |
| Device Class | Class 2 |
Regulatory Classification
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.
