510(k) · Cleared
ClearedAdvantage
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 Nov 6, 2014 as substantially equivalent to K113502 (Lutronic Corporation, 2012) and 1 other predicate after a 147-day review. Its family tree reaches back 11 generations to 1992. 14 later devices descend from it.
- Decided
- Nov 6, 2014
- Review
- 147 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K910422 (1992). 106 ancestors in all, the oldest K820106 (1982). 14 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
- This deviceK141555 AdvantageLutronic Corporation · 2014
- 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 · 2 generations on · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK201594 Primelase ExcellenceHigh Technology Products S.L.U · 2020
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
- This deviceK141555 AdvantageLutronic Corporation · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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
- K221571InMode Multi-systemInMode, Ltd. · 2022 · 2 generations on2descendants
- K201594Primelase ExcellenceHigh Technology Products S.L.U · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −2 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| −1 | K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060 | Lumenis, Ltd. | 2014 | — |
| 0 (this device) | K141555 | Advantage | Lutronic Corporation | 2014 | — |
| +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 | — |
| +2 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +3 | K201594 | Primelase Excellence | High Technology Products S.L.U | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113502 | Advantage Laser SystemSummary page 6…K141555 Page 2 of 3 3. Predicate Devices Lutronic Corporation ADVANTAGE Laser System, cleared in 510(k) K113502 and the Lumenis Ltd. ET LighSheer 1060, cleared in 510(k) K133319. 4. Device Description… | 2012 |
| * | K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060Summary page 6…ices Lutronic Corporation ADVANTAGE Laser System, cleared in 510(k) K113502 and the Lumenis Ltd. ET LighSheer 1060, cleared in 510(k) K133319. 4. Device Description The ADVANTAGE Laser System with D1-1064 Handpiece is a treatment… | 2014 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180719 | InMode Diolaze System | 2018 | 13 |
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 22 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 106 ancestors have a recall of any class.
- Of its descendants, K180719 (Inmode MD, Ltd., 2018) has gone furthest, with 13 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. 2014, 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 D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other…
Read the full statement (315 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 D1-800 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 D1-800 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 D3-800 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.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). 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.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker’s nevi and other benign pigmented lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
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/K141555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141555: Advantage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141555
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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