510(k) · Cleared
ClearedIndigo Portable Laser System, Inddigo Fiberoptics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indigo Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 25, 1996 after a 141-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 25, 1996
- Review
- 141 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK954195 Indigo Portable Laser System, Inddigo FiberopticsIndigo Medical, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK070353 Kelsey Intersitital Laser Therapy SystemKelsey, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK013493 Indigo Optima Laser SystemEthicon Endo-Surgery, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK160392 Novilase Laser Therapy System, Model LTS-2Novian Health, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK023182 Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH…Ethicon Endo-Surgery, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc. · 2007 · cites it directly1descendant
- K013493Indigo Optima Laser SystemEthicon Endo-Surgery, Inc. · 2001 · cites it directly1descendant
- K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc. · 2016 · 2 generations on0descendants
- K023182Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip…Ethicon Endo-Surgery, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954195 | Indigo Portable Laser System, Inddigo Fiberoptics | Indigo Medical, Inc. | 1996 | — |
| +1 | K070353 | Kelsey Intersitital Laser Therapy System | Kelsey, Inc. | 2007 | — |
| +1 | K013493 | Indigo Optima Laser System | Ethicon Endo-Surgery, Inc. | 2001 | — |
| +2 | K160392 | Novilase Laser Therapy System, Model LTS-2 | Novian Health, Inc. | 2016 | — |
| +2 | K023182 | Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima… | Ethicon Endo-Surgery, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K070353 (Kelsey, Inc., 2007) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K954195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954195: Indigo Portable Laser System, Inddigo Fiberoptics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954195
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026