510(k) · Cleared
ClearedInMode Diolaze XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmode MD, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 7, 2017 as substantially equivalent to K151947 (Lumenis, Ltd., 2015) after a 150-day review. Its family tree reaches back 2 generations to 2006. 15 later devices descend from it.
- Decided
- Aug 7, 2017
- Review
- 150 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053628 (2006). 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK053628 Lightsheer Duet Laser SystemLumenis, Inc. · 2006
- 1 generation backK151947 LightSheer Desire Light Laser SystemLumenis, Ltd. · 2015
- This deviceK170738 InMode Diolaze XLInmode MD, Ltd. · 2017
- Descendant · cites it directly · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 8 of its ownK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- Descendant · 3 generations on · 3 of its ownK193367 elysion-proHigh Technology Products S.L.U · 2020
- Descendant · cites it directly · 3 of its ownK173677 InMode VLazeInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · cites it directly13descendants
- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · 2 generations on8descendants
- K193367elysion-proHigh Technology Products S.L.U · 2020 · 3 generations on3descendants
- K173677InMode VLazeInmode MD, Ltd. · 2018 · cites it directly3descendants
- K221571InMode Multi-systemInMode, Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053628 | Lightsheer Duet Laser System | Lumenis, Inc. | 2006 | — |
| −1 | K151947 | LightSheer Desire Light Laser System | Lumenis, Ltd. | 2015 | — |
| 0 (this device) | K170738 | InMode Diolaze XL | Inmode MD, Ltd. | 2017 | — |
| +1 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +2 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +3 | K193367 | elysion-pro | High Technology Products S.L.U | 2020 | — |
| +1 | K173677 | InMode VLaze | Inmode MD, Ltd. | 2018 | — |
| +2 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K151947 | LightSheer Desire Light Laser SystemSummary page 4…cate devices. Manufacturer Device 510(k) No. Lumenis Ltd. Lightsheer Desire (ET) K151947 Page 5-2… | 2015 |
What descends from it? (15)
See all 152 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180719 (Inmode MD, Ltd., 2018) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K151947.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as stable, long-term
reduction in hair counts at 6,9 or 12 months following a treatment regime.
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/K170738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170738: InMode Diolaze XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170738
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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