510(k) · Cleared
ClearedIndigo Optima Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 13, 2001 as substantially equivalent to K963969 (Indigo Medical, Inc., 1997) and 6 other predicates after a 52-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Dec 13, 2001
- Review
- 52 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K963969 (1997). 7 ancestors in all, the oldest K954195 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK963969 Indigo Portable Laser System with Temperature Feedback -Model Idl…Indigo Medical, Inc. · 1997
- 1 generation backK990851 Indigo Laseroptic Treatment SystemIndigo Medical, Inc. · 1999
- This deviceK013493 Indigo Optima Laser SystemEthicon Endo-Surgery, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK023182 Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH…Ethicon Endo-Surgery, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K023182Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip…Ethicon Endo-Surgery, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963969 | Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power… | Indigo Medical, Inc. | 1997 | — |
| −1 | K990851 | Indigo Laseroptic Treatment System | Indigo Medical, Inc. | 1999 | — |
| 0 (this device) | K013493 | Indigo Optima Laser System | Ethicon Endo-Surgery, Inc. | 2001 | — |
| +1 | K023182 | Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima… | Ethicon Endo-Surgery, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K963969 | Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options…Summary page 1…Predicate Device . The Indigo OPTIMA Laser System is substantially equivalent to the current Indigo LaserOptic® Treatment System cleared by FDA on December 23, 1997 (K963969), as well as the following submissions: e K954195, cleared January 25, 1996, indigo Portable Laser System Model IDL 830 and ind… | 1997 |
| * | K954195 | Indigo Portable Laser System, Inddigo FiberopticsSummary page 1…is substantially equivalent to the current Indigo LaserOptic® Treatment System cleared by FDA on December 23, 1997 (K963969), as well as the following submissions: e K954195, cleared January 25, 1996, indigo Portable Laser System Model IDL 830 and indigo Fiberoptics e K955758, cleared February 27, 199… | 1996 |
| * | K955758 | Indigo Medical Model Idl 830ESummary page 1…ber 23, 1997 (K963969), as well as the following submissions: e K954195, cleared January 25, 1996, indigo Portable Laser System Model IDL 830 and indigo Fiberoptics e K955758, cleared February 27, 1996, Indigo Portable Laser System with Temperature Feedback Model 830e e K963081, cleared February 21, 19… | 1996 |
| * | K963081 | Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological…Summary page 1…go Portable Laser System Model IDL 830 and indigo Fiberoptics e K955758, cleared February 27, 1996, Indigo Portable Laser System with Temperature Feedback Model 830e e K963081, cleared February 21, 1997, indigo Models IDL 830 and IDL 830e Laser Systems e K990851, cleared March 30, 1999, indigo Diffuser-… | 1997 |
| * | K990851 | Indigo Laseroptic Treatment SystemSummary page 1…ry 27, 1996, Indigo Portable Laser System with Temperature Feedback Model 830e e K963081, cleared February 21, 1997, indigo Models IDL 830 and IDL 830e Laser Systems e K990851, cleared March 30, 1999, indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option e K003952, cleared March 16, 2001, Indig… | 1999 |
| * | K003952 | Indigo Laseroptic Treatment SystemSummary page 1…February 21, 1997, indigo Models IDL 830 and IDL 830e Laser Systems e K990851, cleared March 30, 1999, indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option e K003952, cleared March 16, 2001, Indigo LaserOptic Treatment System e K003953, cleared March 16, 2001, Indigo Diffuser-Tip Fiberoptic wi… | 2001 |
| * | K003953 | Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001Summary page 1…K990851, cleared March 30, 1999, indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option e K003952, cleared March 16, 2001, Indigo LaserOptic Treatment System e K003953, cleared March 16, 2001, Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option Device Description The indigo® OPTIMA L… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023182 | Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip… | 2002 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K023182 (Ethicon Endo-Surgery, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K963969.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 OPTIMA Laser 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 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser…
Read the full statement (120 words)
The indigo OPTIMA Laser 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 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.
The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.
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/K013493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013493: Indigo Optima Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013493
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026