# K140754: Cooper Surgical Leisegang Colposcope System

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Oct 23, 2014 after 211 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940094 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940094: Colposcopes and Accessories, Leisegang Medical, Inc. (1995) Summary page 4.
- K981958: Leisegang Video Colposcope, Netoptix Corp. (1998) Summary page 4.
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope, Medgyn Products, Inc. (2013) Summary page 4.

## Most influential descendants
- K160341: Colposcope System (2016), 0 descendants of its own

## Indications for use
The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcopes may be viewed directly and/or on a color monitor (if so equipped). Cooper Surgical Leisegang Colposcopes are intended for use in hospitals, clinics, and doctor’s offices.

Source page: https://510kreport.com/device/K140754
Methodology: https://510kreport.com/methodology