510(k) · Cleared
ClearedAdvantage Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · GEX Powered Laser Surgical Instrument
Cleared on Apr 5, 2012 as substantially equivalent to K053628 (Lumenis, Inc., 2006) after a 132-day review. Its family tree reaches back 1 generation to 2006. 15 later devices descend from it.
- Decided
- Apr 5, 2012
- Review
- 132 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053628 (2006). 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK053628 Lightsheer Duet Laser SystemLumenis, Inc. · 2006
- This deviceK113502 Advantage Laser SystemLutronic Corporation · 2012
- Descendant · cites it directly · 14 of its ownK141555 AdvantageLutronic Corporation · 2014
- Descendant · 2 generations on · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- Descendant · 3 generations on · 8 of its ownK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- Descendant · 4 generations on · 3 of its ownK193367 elysion-proHigh Technology Products S.L.U · 2020
- Descendant · 3 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- K141555AdvantageLutronic Corporation · 2014 · cites it directly14descendants
- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · 2 generations on13descendants
- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · 3 generations on8descendants
- K193367elysion-proHigh Technology Products S.L.U · 2020 · 4 generations on3descendants
- K221571InMode Multi-systemInMode, Ltd. · 2022 · 3 generations on2descendants
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) | K113502 | Advantage Laser System | Lutronic Corporation | 2012 | — |
| +1 | K141555 | Advantage | Lutronic Corporation | 2014 | — |
| +2 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +3 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +4 | K193367 | elysion-pro | High Technology Products S.L.U | 2020 | — |
| +3 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K053628 | Lightsheer Duet Laser SystemSummary page 1…Product Code: GEX Panel: General & Plastic Surgery 3. Predicate Device Lumenis LightSheer Duet Laser System (K053628) 4. Device Description The ADVANTAGE Laser System is a non-invasive aesthetic laser. The system delivers pulsed… | 2006 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141555 | Advantage | 2014 | 14 |
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. 2012, 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 ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I -VI), including tanned skin. The ADVANTAGE Laser System with H1 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign…
Read the full statement (163 words)
The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I -VI), including tanned skin.
The ADVANTAGE Laser System with H1 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with H1 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9 and 12 months, and the treatment of benign pigmented lesions and leg veins.
The ADVANTAGE Laser System with H3 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9 and 12 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113502: Advantage 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/K113502
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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