510(k) · Cleared
ClearedEplus Skin Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 11, 2012 as substantially equivalent to K041959 (Syneron Medical, Ltd., 2004) and 8 other predicates after a 164-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Jun 11, 2012
- Review
- 164 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 18 generations to K943450 (1995). 271 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK090025 Matrix RF ApplicatorSyneron Medical, Ltd. · 2010
- 1 generation backK110672 Etwo Skin Treatment SystemSyneron, Ltd. · 2011
- This deviceK113868 Eplus Skin Treatment SystemSyneron, Ltd. · 2012
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 6 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 5 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 4 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK090025 Matrix RF ApplicatorSyneron Medical, Ltd. · 2010
- 1 generation backK110672 Etwo Skin Treatment SystemSyneron, Ltd. · 2011
- This deviceK113868 Eplus Skin Treatment SystemSyneron, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −6 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −5 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −4 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −3 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −2 | K090025 | Matrix RF Applicator | Syneron Medical, Ltd. | 2010 | — |
| −1 | K110672 | Etwo Skin Treatment System | Syneron, Ltd. | 2011 | — |
| 0 (this device) | K113868 | Eplus Skin Treatment System | Syneron, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 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 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 29 | 0 |
| 2003 | 28 | 0 |
| 2004 | 14 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 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? (9)
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 |
|---|---|---|---|
| * | K041959 | Polaris DS/CometSummary page 3…7 Medical LTD Syneron Device Name 510k No Date of Clearance Polaris DS / Comet Applicator K041959 November 8, 2004 Polaris LV K030186 April 14, 2003… | 2004 |
| * | K030186 | Polris LVSummary page 3…10k No Date of Clearance Polaris DS / Comet Applicator K041959 November 8, 2004 Polaris LV K030186 April 14, 2003 Polaris WR K03 1671 December 1, 2003… | 2003 |
| * | K031671 | Polaris WRSummary page 3…K041959 November 8, 2004 Polaris LV K030186 April 14, 2003 Polaris WR K03 1671 December 1, 2003 Aurora SR K031993 August 1, 2003 AC app… | 2003 |
| * | K031993 | Aurora SRSummary page 3…030186 April 14, 2003 Polaris WR K03 1671 December 1, 2003 Aurora SR K031993 August 1, 2003 AC applicator, Aurora AC K032514 January 27, 2004 Auro… | 2003 |
| * | K032514 | AC Applicator, Aurora ACSummary page 3…03 1671 December 1, 2003 Aurora SR K031993 August 1, 2003 AC applicator, Aurora AC K032514 January 27, 2004 Aurora DS, DS applicator K050796 April 12. 2005 Aurora… | 2004 |
| * | K050796 | Aurora DS, DS ApplicatorSummary page 3…031993 August 1, 2003 AC applicator, Aurora AC K032514 January 27, 2004 Aurora DS, DS applicator K050796 April 12. 2005 Aurora SR and SRA applicator K050452 March 9. 2005 Polaris… | 2005 |
| * | K050452 | Aurora SR and Sra ApplicatorSummary page 3…032514 January 27, 2004 Aurora DS, DS applicator K050796 April 12. 2005 Aurora SR and SRA applicator K050452 March 9. 2005 Polaris LV, LVA applicator K052324 September 14, 2005 eTwo S… | 2005 |
| * | K052324 | Polaris LV, Lva ApplicatorSummary page 3…K050796 April 12. 2005 Aurora SR and SRA applicator K050452 March 9. 2005 Polaris LV, LVA applicator K052324 September 14, 2005 eTwo Skin Treatment System K1 10672 October 03, 2011 Performance St… | 2005 |
| * | K110672 | Etwo Skin Treatment SystemSummary page 3…050452 March 9. 2005 Polaris LV, LVA applicator K052324 September 14, 2005 eTwo Skin Treatment System K1 10672 October 03, 2011 Performance Standards: ePlus Skin Treatment System complies with:… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 11 of the 271 ancestors have a recall of any class.
- 1 other device also cites its predicate K041959.
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 ePlus Skin Treatment system is intended for dermatological procedures. The DS applicator is indicated for the removal of unwanted hair from skin types I-VI. and to effect stable long-term, or permanent, hair reduction* The DSL applicator is indicated for hair removal, permanent hair reduction*. The applicator is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The LV applicator is indicated for treatment of…
Read the full statement (279 words)
The ePlus Skin Treatment system is intended for dermatological procedures.
The DS applicator is indicated for the removal of unwanted hair from skin types I-VI. and to effect stable long-term, or permanent, hair reduction*
The DSL applicator is indicated for hair removal, permanent hair reduction*. The applicator is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
The LV applicator is indicated for treatment of vascular lesions.
The LVA applicator is indicated for treatment of vascular lesions.
The WRA applicator is indicated for non invasive wrinkles treatment.
The SR applicator is intended for superficial benign vascular and pigmented lesion treatment such as: lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots. The SR treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The SRA applicator is intended for superficial benign vascular and pigmented lesion treatment such as: lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots. The SRA treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The AC applicator is indicated for the treatment of moderate inflammatory acne vulgaries.
The Sublative RE applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
The Sublime applicator is indicated for non invasive wrinkles treatment.
*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 regimen
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113868: Eplus Skin Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113868
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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