510(k) · Cleared

Cleared

Indigo Laseroptic Treatment System

K990851510(k) TraditionalCleared Mar 30, 199915-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 Mar 30, 1999 as substantially equivalent to K963969 (Indigo Medical, Inc., 1997) after a 15-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.

Decided: Mar 30, 1999
Review: 15 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963969 (1997). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK963969 Indigo Portable Laser System with Temperature Feedback -Model Idl…Indigo Medical, Inc. · 1997
This deviceK990851 Indigo Laseroptic Treatment SystemIndigo Medical, Inc. · 1999
Descendant · cites it directly · 3 of its ownK022655 Trimedyne Side Firing Needle with Vent SheathTrimedyne, Inc. · 2002
Descendant · 2 generations on · 2 of its ownK050412 VapormaxTrimedyne, Inc. · 2005
Descendant · 3 generations on · 1 of its ownK053457 Vapormax IITrimedyne, Inc. · 2005
Descendant · cites it directly · 1 of its ownK013493 Indigo Optima Laser SystemEthicon Endo-Surgery, Inc. · 2001
Descendant · 4 generations on · 0 of its ownK233157 VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all

K022655Trimedyne Side Firing Needle with Vent SheathTrimedyne, Inc. · 2002 · cites it directly3descendants
K050412VapormaxTrimedyne, Inc. · 2005 · 2 generations on2descendants
K053457Vapormax IITrimedyne, Inc. · 2005 · 3 generations on1descendant
K013493Indigo Optima Laser SystemEthicon Endo-Surgery, Inc. · 2001 · cites it directly1descendant
K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963969	Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power…	Indigo Medical, Inc.	1997	—
0 (this device)	K990851	Indigo Laseroptic Treatment System	Indigo Medical, Inc.	1999	—
+1	K022655	Trimedyne Side Firing Needle with Vent Sheath	Trimedyne, Inc.	2002	—
+2	K050412	Vapormax	Trimedyne, Inc.	2005	—
+3	K053457	Vapormax II	Trimedyne, Inc.	2005	—
+1	K013493	Indigo Optima Laser System	Ethicon Endo-Surgery, Inc.	2001	—
+4	K233157	VaporMAX LDD; MOJo LDD; MegaJOULE LDD	Innovaquartz, LLC	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2005	2	0
2024	1	0

FIG. 1 — Lineage of K990851, 1997–2024Source: 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.

Planning a device in GEX? 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? (1)

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	Applicant	Decided	Recalls
*	K963969	Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options… Summary page 1 …emperature Sensing Option is substantially equivalent to the current Indigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option cleared by FDA on December 23, 1997 (K963969). Device Description: The Indigo Diffuser- Tip™ Fiberoptic is a sterile, single-use, disposable fiberoptic which is 3 meters in…	Indigo Medical, Inc.	1997	—

Also cleared against K963969: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K022655	Trimedyne Side Firing Needle with Vent Sheath	Trimedyne, Inc.	2002	3
K013493	Indigo Optima Laser System	Ethicon Endo-Surgery, Inc.	2001	1

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?

Its one ancestor has no recall.
Of its descendants, K022655 (Trimedyne, Inc., 2002) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K963969.

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	—

What is it indicated for?

The Indigo LaserOptic™ Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990851 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990851: Indigo Laseroptic Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990851

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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