510(k) · Cleared
ClearedIndigo Medical Model Idl 830E
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 Feb 16, 1996 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 701 later devices descend from it.
- Decided
- Feb 16, 1996
- Review
- 59 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
701 later devices descend from it, 2 citing it directly.
- This deviceK955758 Indigo Medical Model Idl 830EIndigo Medical, Inc. · 1996
- Descendant · cites it directly · 698 of its ownK982629 Dornier Medilas DDornier Surgical Products, Inc. · 1998
- Descendant · 2 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- Descendant · 3 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · 4 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 5 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
Showing 5 of 701 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 701 · See all- K982629Dornier Medilas DDornier Surgical Products, Inc. · 1998 · cites it directly698descendants
- K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 2 generations on695descendants
- K030186Polris LVSyneron Medical, Ltd. · 2003 · 3 generations on680descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 4 generations on678descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 5 generations on476descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955758 | Indigo Medical Model Idl 830E | Indigo Medical, Inc. | 1996 | — |
| +1 | K982629 | Dornier Medilas D | Dornier Surgical Products, Inc. | 1998 | — |
| +2 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
| +3 | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +5 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 18 | 0 |
| 2009 | 17 | 0 |
| 2010 | 19 | 0 |
| 2011 | 15 | 0 |
| 2012 | 17 | 0 |
| 2013 | 21 | 0 |
| 2014 | 29 | 0 |
| 2015 | 25 | 0 |
| 2016 | 39 | 0 |
| 2017 | 35 | 0 |
| 2018 | 35 | 0 |
| 2019 | 25 | 0 |
| 2020 | 40 | 0 |
| 2021 | 32 | 0 |
| 2022 | 51 | 0 |
| 2023 | 45 | 0 |
| 2024 | 76 | 0 |
| 2025 | 88 | 0 |
| 2026 | 52 | 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? (701)
See all 7012 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, K982629 (Dornier Surgical Products, Inc., 1998) has gone furthest, with 698 descendants 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/K955758 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955758: Indigo Medical Model Idl 830E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955758
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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