510(k) · Cleared
ClearedMatrix RF Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Medical, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 17, 2008 as substantially equivalent to K052936 (Thermage, Inc., 2007) and 4 other predicates after a 273-day review. Its family tree reaches back 15 generations to 1995. 102 later devices descend from it.
- Decided
- Sep 17, 2008
- Review
- 273 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K943450 (1995). 223 ancestors in all, the oldest K800617 (1980). 102 later devices descend from it, 5 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 2 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 1 generation backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- This deviceK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- Descendant · cites it directly · 64 of its ownK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · 2 generations on · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · 3 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · cites it directly · 24 of its ownK102461 FractoraInvasix, Ltd. · 2011
- Descendant · 4 generations on · 20 of its ownK192545 PotenzaJeisys Medical Incorporated · 2020
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 3 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 2 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 1 generation backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- This deviceK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011 · cites it directly64descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · 2 generations on57descendants
- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 3 generations on38descendants
- K102461FractoraInvasix, Ltd. · 2011 · cites it directly24descendants
- K192545PotenzaJeisys Medical Incorporated · 2020 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −3 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −2 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −1 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| 0 (this device) | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| +1 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +2 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +3 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +1 | K102461 | Fractora | Invasix, Ltd. | 2011 | — |
| +4 | K192545 | Potenza | Jeisys Medical Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 13 | 0 |
| 1996 | 18 | 0 |
| 1997 | 14 | 0 |
| 1998 | 12 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 20 | 0 |
| 2002 | 25 | 0 |
| 2003 | 20 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 20 | 0 |
| 2025 | 15 | 0 |
| 2026 | 11 | 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? (5)
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 |
|---|---|---|---|
| * | K052936 | Thermage Thermacool SystemSummary page 1…mission for the Matrix RF Applicator that is substantially equivalent to the following cleared devices: ThermaCool (Thermage, K052936); UltraPulse Encore (Lumenis, K022060); Lux 1540 (Palomar, K061652); Lovely/Harmony (… | 2007 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…substantially equivalent to the following cleared devices: ThermaCool (Thermage, K052936); UltraPulse Encore (Lumenis, K022060); Lux 1540 (Palomar, K061652); Lovely/Harmony (MSq, currently Alma Lasers, K042000);… | 2002 |
| * | K061652 | Palomar LUX1540 HandpieceSummary page 1…nt to the following cleared devices: ThermaCool (Thermage, K052936); UltraPulse Encore (Lumenis, K022060); Lux 1540 (Palomar, K061652); Lovely/Harmony (MSq, currently Alma Lasers, K042000); Portrait PSR 3 (Rhytec, K0723… | 2007 |
| * | K042000 | Modified MSQ Family of Lovely Light/Laser SystemsSummary page 1…age, K052936); UltraPulse Encore (Lumenis, K022060); Lux 1540 (Palomar, K061652); Lovely/Harmony (MSq, currently Alma Lasers, K042000); Portrait PSR 3 (Rhytec, K072394). Device Description: The Matrix RF Applicator is composed of a connect… | 2004 |
| * | K072394 | Portrait Stand-OffSummary page 1…Lumenis, K022060); Lux 1540 (Palomar, K061652); Lovely/Harmony (MSq, currently Alma Lasers, K042000); Portrait PSR 3 (Rhytec, K072394). Device Description: The Matrix RF Applicator is composed of a connector, cable, handpiece and disposable… | 2007 |
What descends from it? (102)
See all 1025 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 13 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 10 of the 223 ancestors have a recall of any class.
- Of its descendants, K101510 (Endymed Medical, Ltd., 2011) has gone furthest, with 64 descendants of its own.
- 1 other device also cites its predicate K052936.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073572: Matrix RF Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073572
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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