510(k) · Cleared

Cleared

Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications

K963081510(k) TraditionalCleared Feb 21, 1997197-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Indigo Medical, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Feb 21, 1997 after a 197-day review. The FDA summary names no predicate by number. 2 of the 37 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.

Decided: Feb 21, 1997
Review: 197 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

36 later devices descend from it, 2 citing it directly. 2 of the 37 devices in this family, counting this one, have a Class I recall.

This deviceK963081 Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for…Indigo Medical, Inc. · 1997
Descendant · cites it directly · 33 of its ownK053087 Visualase Cooled Laser Applicator System, Laser Diffusing Fiber…Biotex, Inc. · 2006 · Recalled
Descendant · 2 generations on · 26 of its ownK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
Descendant · 3 generations on · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
Descendant · 4 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
Descendant · 5 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2001high 5 (2017) · low 0 (2003)2026

Class I recalls in this family

K143457 NeuroBlate System6 generations on · 2015
K171255 Monteris Medical NeuroBlate System6 generations on · 2017

Most influential descendants

Showing 5 of 36 · See all

K053087Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemBiotex, Inc. · 2006 · cites it directly33descendants
K071328Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · 2 generations on26descendants
K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · 3 generations on22descendants
K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 4 generations on21descendants
K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 5 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K963081	Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General…	Indigo Medical, Inc.	1997	—
+1	K053087	Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling…	Biotex, Inc.	2006	5
+2	K071328	Visualase Thermal Therapy System	Biotex, Inc.	2007	1
+3	K081509	Monteris Medical Autolitt Laser Probe	Monteris Medical,	2009	—
+4	K120561	Neuroblate System	Monteris Medical, Inc.	2013	1
+5	K131955	Neuroblate (TM) System	Monteris Medical, Inc.	2013	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2013	3	0
2014	1	0
2015	1	1
2016	2	0
2017	5	1
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2022	3	0
2023	3	0
2024	1	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K963081, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (36)

See all 36

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053087	Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System	Biotex, Inc.	2006	33
K013493	Indigo Optima Laser System	Ethicon Endo-Surgery, Inc.	2001	1

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K053087 (Biotex, Inc., 2006) has gone furthest, with 33 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

https://510kreport.com/device/K963081 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963081: Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963081

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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