510(k) · Cleared
ClearedIndigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip Fiberoptic,Optima Laser Cart with Prints
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 Oct 24, 2002 as substantially equivalent to K013493 (Ethicon Endo-Surgery, Inc., 2001) after a 30-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Oct 24, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963969 (1997). 8 ancestors in all, the oldest K954195 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK963969 Indigo Portable Laser System with Temperature Feedback -Model Idl…Indigo Medical, Inc. · 1997
- 2 generations backK990851 Indigo Laseroptic Treatment SystemIndigo Medical, Inc. · 1999
- 1 generation backK013493 Indigo Optima Laser SystemEthicon Endo-Surgery, Inc. · 2001
- This deviceK023182 Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH…Ethicon Endo-Surgery, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963969 | Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power… | Indigo Medical, Inc. | 1997 | — |
| −2 | K990851 | Indigo Laseroptic Treatment System | Indigo Medical, Inc. | 1999 | — |
| −1 | K013493 | Indigo Optima Laser System | Ethicon Endo-Surgery, Inc. | 2001 | — |
| 0 (this device) | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K013493 | Indigo Optima Laser System | 2001 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
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 andor 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 andor 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 as stated in the FDA summary.
https://510kreport.com/device/K023182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023182: Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip Fiberoptic,Optima Laser Cart with Prints.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023182
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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