510(k) · Cleared
ClearedSmoothshapes System, 11318-120V, 11319-230V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eleme Medical, Inc. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Apr 2, 2010 as substantially equivalent to K083629 (Eleme Medical, Inc., 2009) and 1 other predicate after a 66-day review. Its family tree reaches back 15 generations to 1995. 26 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 66 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 59 ancestors in all, the oldest K800617 (1980). 26 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 2 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 1 generation backK083629 SmoothshapesEleme Medical, Inc. · 2009
- This deviceK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
- Descendant · cites it directly · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · 2 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
- Descendant · 2 generations on · 21 of its ownK150230 SculpSureCynosure, Inc. · 2015
- Descendant · 3 generations on · 20 of its ownK160470 SculpSureCynosure, Inc. · 2016
- Descendant · 4 generations on · 10 of its ownK171111 SculpsureCynosure, Inc. · 2017
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 backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 3 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 2 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 1 generation backK083629 SmoothshapesEleme Medical, Inc. · 2009
- This deviceK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · cites it directly25descendants
- K150724SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
- K150230SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
- K160470SculpSureCynosure, Inc. · 2016 · 3 generations on20descendants
- K171111SculpsureCynosure, Inc. · 2017 · 4 generations on10descendants
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 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −3 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −2 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −1 | K083629 | Smoothshapes | Eleme Medical, Inc. | 2009 | — |
| 0 (this device) | K100230 | Smoothshapes System, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010 | — |
| +1 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +2 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
| +2 | K150230 | SculpSure | Cynosure, Inc. | 2015 | — |
| +3 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| +4 | K171111 | Sculpsure | Cynosure, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 NUV? 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 NUV device
- #1 K261582 Vacuum Roller RF Slimming Device for Medical…score 16.7 · 17 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 |
|---|---|---|---|
| * | K083629 | SmoothshapesSummary page 1…CFR section 878.4810 Device panel General & Plastic Surgery Legally marketed Elem6 SmoothShapes (K083629) predicate devices Syneron Velashape (K07 1872) Elem6 Medical, Inc.… | 2009 |
| * | K071872 | VelashapeSummary page 1…General & Plastic Surgery Legally marketed Elem6 SmoothShapes (K083629) predicate devices Syneron Velashape (K07 1872) Elem6 Medical, Inc. Submitter ~Heron Cove Office Park… | 2007 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123971 | Cynosure 1064NM Diode Laser | 2013 | 25 |
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 15 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 3 of the 59 ancestors have a recall of any class.
- Of its descendants, K123971 (Cynosure, Inc., 2013) has gone furthest, with 25 descendants of its own.
How does its category compare?
All NUV devicesNUV Massager, Vacuum, Light Induced Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NUV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NUV
99in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUV
No recall names NUV since 2007.
Adverse event reports per year · NUV
1in 2020
MAUDE reports naming product code NUV, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 99 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Elem6 Medical SMOOTHSHAPES® XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100230: Smoothshapes System, 11318-120V, 11319-230V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100230
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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