510(k) · Cleared
Clearedelysion-pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
High Technology Products S.L.U · GEX Powered Laser Surgical Instrument
Cleared on Mar 12, 2020 as substantially equivalent to K191321 (High Technology Products S.L.U, 2019) and 2 other predicates after a 99-day review. Its family tree reaches back 23 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 12, 2020
- Review
- 99 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K943450 (1995). 527 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- 2 generations backK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- 1 generation backK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- This deviceK193367 elysion-proHigh Technology Products S.L.U · 2020
- Descendant · cites it directly · 1 of its ownK214049 Leaseir MHR XcellLeaseir Technologies, Slu · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK253251 Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and…Leaseir Technologies, Slu · 2026
- Descendant · cites it directly · 0 of its ownK222369 PURE LaserEndymed Medical, Ltd. · 2022
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 10 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 9 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 6 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 5 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 4 generations backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- 3 generations backK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- 2 generations backK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- 1 generation backK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- This deviceK193367 elysion-proHigh Technology Products S.L.U · 2020
Most influential descendants
Showing 3 of 3 · See all- K214049Leaseir MHR XcellLeaseir Technologies, Slu · 2022 · cites it directly1descendant
- K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu · 2026 · 2 generations on0descendants
- K222369PURE LaserEndymed Medical, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −10 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −9 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −6 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −5 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −4 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| −3 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| −2 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| −1 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| 0 (this device) | K193367 | elysion-pro | High Technology Products S.L.U | 2020 | — |
| +1 | K214049 | Leaseir MHR Xcell | Leaseir Technologies, Slu | 2022 | 1 |
| +2 | K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b)… | Leaseir Technologies, Slu | 2026 | — |
| +1 | K222369 | PURE Laser | Endymed Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 25 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 30 | 0 |
| 1999 | 26 | 0 |
| 2000 | 34 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 15 | 0 |
| 2007 | 16 | 0 |
| 2008 | 18 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K191321 | Primelase ExcellenceSummary page 5…Device Class 21 CFR 878.4810 GEX Class II 5.3 Legally Marketed Equivalent Device 1. Primelase Excellence - K191321 by High Technology Products, S.L.U (Same company). 2. The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Techn… | 2019 |
| * | K140009 | Soprano Ice Multi-Application & Multi-Technology PlatformSummary page 5…cts, S.L.U (Same company). 2. The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL Soprano XL and Soprano ICE] – K140009 by Alma Lasers Ltd. 3. Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity – K170179 by Lu… | 2014 |
| * | K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinitySummary page 5…Platforms [Soprano XL Soprano XL and Soprano ICE] – K140009 by Alma Lasers Ltd. 3. Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity – K170179 by Lumenis Ltd. Page 2 of 6 =… | 2017 |
What descends from it? (3)
2 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 25 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 26 of the 527 ancestors have a recall of any class.
- Of its descendants, K214049 (Leaseir Technologies, Slu, 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K191321.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include:
• Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• Treatment of Pseudofolliculitis barbae (PFB)
• Use on all skin types (Fitzpatrick I-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193367: elysion-pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193367
Report an extraction error
Are you the manufacturer?
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