510(k) · Cleared
ClearedIRIS Thermocoagulator and Digital Colposcope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liger Medical, LLC · HGI Electrocautery, Gynecologic (And Accessories)
Cleared on Apr 23, 2021 as substantially equivalent to K152843 (Liger Medical, LLC, 2016) and 1 other predicate after a 206-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Apr 23, 2021
- Review
- 206 days
- Class
- Class II
- Product code
- HGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940094 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 3 generations backK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- 2 generations backK122973 AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013
- 1 generation backK161871 EVA (Enhanced Visual Assessment) SystemMobileodt, Ltd. · 2016
- This deviceK202915 IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −3 | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| −2 | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope | Medgyn Products, Inc. | 2013 | — |
| −1 | K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt, Ltd. | 2016 | — |
| 0 (this device) | K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152843 | Liger Medical HTU-110Summary page 4…510(k) DateCleared Liger Medical LLC T Liger Medical Thermocoagulator HTU-110 K152843 06/24/2016 Copyright @ Liger Medical LLC. All rights reserved. The contents ofthisdocument are proprietaryto Liger… | 2016 |
| * | K161871 | EVA (Enhanced Visual Assessment) SystemSummary page 5…om 510(k) Summary: K202915 MobileODT Ltd. I EVA (Enhanced Visual Assessment) System K161871 112/19/201 The predicate devices have not been subject toa design-related recall. 5. Device Description Th… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All HGI devicesHGI Electrocautery, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HGI
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · HGI
Too few HGI 510(k)s in any year since 2007 to give a median.
Recalls per year · HGI
7in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGI
41in 2025
MAUDE reports naming product code HGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 1 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 30 |
| 2019 | 0 | — | 3 | 127 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 1 | — | 7 | 100 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202915: IRIS Thermocoagulator and Digital Colposcope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202915
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026