# K160380: LT-300 HD

- Pathway: 510(k) (Traditional)
- Applicant: Lutech Industries, Inc.
- Decided: May 13, 2016 after 93 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: 1 generation back to K143119 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143119: LT-300 Video Colposcope, Lutech Industries, Inc. (2014) Summary page 4.

## Indications for use
The LT-300 HD digital video 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/K160380
Methodology: https://510kreport.com/methodology