# K143119: LT-300 Video Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Lutech Industries, Inc.
- Decided: Dec 18, 2014 after 49 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160380: LT-300 HD (2016), 0 descendants of its own

## Indications for use
The LT-300 Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.

Source page: https://510kreport.com/device/K143119
Methodology: https://510kreport.com/methodology