510(k) · Cleared
ClearedLegend X Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pollogen, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 17, 2023 after a 29-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Oct 17, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
4 later devices descend from it, 3 citing it directly.
- This deviceK232903 Legend X PlatformPollogen, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK240999 Legend X Applicator VOPollogen, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253803 MILAN SystemLumenis Be, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252576 Legend X PlatformPollogen, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243217 Legend X Desktop SystemPollogen, Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K240999Legend X Applicator VOPollogen, Ltd. · 2024 · cites it directly1descendant
- K253803MILAN SystemLumenis Be, Ltd. · 2026 · 2 generations on0descendants
- K252576Legend X PlatformPollogen, Ltd. · 2025 · cites it directly0descendants
- K243217Legend X Desktop SystemPollogen, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K232903 | Legend X Platform | Pollogen, Ltd. | 2023 | — |
| +1 | K240999 | Legend X Applicator VO | Pollogen, Ltd. | 2024 | — |
| +2 | K253803 | MILAN System | Lumenis Be, Ltd. | 2026 | — |
| +1 | K252576 | Legend X Platform | Pollogen, Ltd. | 2025 | — |
| +1 | K243217 | Legend X Desktop System | Pollogen, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081938 | FDA’s K081938 is Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| Kept off the family tree | K212909 | FDA’s K212909 is VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2022 |
What descends from it? (4)
3 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, K240999 (Pollogen, Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Legend X Platform and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).
It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy and for muscle conditioning to stimulate healthy muscles (Applicators 1-3).
Legend X Platform is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend X Platform is intended to be operated by a trained professional who is present to monitor treatment.
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/K232903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232903: Legend X Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232903
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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