510(k) · Cleared
ClearedLightSheer Desire Light Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 12, 2015 as substantially equivalent to K053628 (Lumenis, Inc., 2006) after a 28-day review. Its family tree reaches back 1 generation to 2006. 27 later devices descend from it.
- Decided
- Aug 12, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053628 (2006). 27 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK053628 Lightsheer Duet Laser SystemLumenis, Inc. · 2006
- This deviceK151947 LightSheer Desire Light Laser SystemLumenis, Ltd. · 2015
- Descendant · cites it directly · 15 of its ownK170738 InMode Diolaze XLInmode MD, Ltd. · 2017
- Descendant · cites it directly · 14 of its ownK170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet…Lumenis, Ltd. · 2017
- Descendant · 2 generations on · 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 · 2 generations on · 3 of its ownK192483 MeDioStarAsclepion Laser Technologies GmbH · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K170738InMode Diolaze XLInmode MD, Ltd. · 2017 · cites it directly15descendants
- K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd. · 2017 · cites it directly14descendants
- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · 2 generations on13descendants
- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · 2 generations on8descendants
- K192483MeDioStarAsclepion Laser Technologies GmbH · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053628 | Lightsheer Duet Laser System | Lumenis, Inc. | 2006 | — |
| 0 (this device) | K151947 | LightSheer Desire Light Laser System | Lumenis, Ltd. | 2015 | — |
| +1 | K170738 | InMode Diolaze XL | Inmode MD, Ltd. | 2017 | — |
| +1 | K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Lumenis, Ltd. | 2017 | — |
| +2 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +2 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +2 | K192483 | MeDioStar | Asclepion Laser Technologies GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K053628 | Lightsheer Duet Laser SystemSummary page 4…ss II Regulation Number: 21 CFR 878.4810 Panel: General & Plastic Surgery Predicate Device: LightSheer Duet Laser System, cleared under K053628. Special 510(k) LightSheer Desire Light Laser System 510(k) Summary… | 2006 |
What descends from it? (27)
See all 274 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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin. The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of…
Read the full statement (149 words)
The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin.
The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.
* Note: Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of 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/K151947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151947: LightSheer Desire Light Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151947
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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