# K202915: IRIS Thermocoagulator and Digital Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Liger Medical, LLC
- Decided: Apr 23, 2021 after 206 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940094 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152843: Liger Medical HTU-110, Liger Medical, LLC (2016) Summary page 4.
- K161871: EVA (Enhanced Visual Assessment) System, Mobileodt, Ltd. (2016) Summary page 5.

## Indications for use
The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing abnormalities as needed for a colposcopy exam.

Source page: https://510kreport.com/device/K202915
Methodology: https://510kreport.com/methodology