510(k) · Cleared
ClearedSmoothshapes
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 Feb 19, 2009 as substantially equivalent to K053611 (Bicellulase, Inc., 2006) and 2 other predicates after a 73-day review. Its family tree reaches back 14 generations to 1995. 27 later devices descend from it.
- Decided
- Feb 19, 2009
- Review
- 73 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K943450 (1995). 58 ancestors in all, the oldest K800617 (1980). 27 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 2 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 1 generation backK061603 SmoothshapesBiocellulase, Inc. · 2006
- This deviceK083629 SmoothshapesEleme Medical, Inc. · 2009
- Descendant · cites it directly · 26 of its ownK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
- Descendant · 2 generations on · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · 3 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
- Descendant · 3 generations on · 21 of its ownK150230 SculpSureCynosure, Inc. · 2015
- Descendant · 4 generations on · 20 of its ownK160470 SculpSureCynosure, Inc. · 2016
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 2 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 1 generation backK061603 SmoothshapesBiocellulase, Inc. · 2006
- This deviceK083629 SmoothshapesEleme Medical, Inc. · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010 · cites it directly26descendants
- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · 2 generations on25descendants
- K150724SculpSureCynosure, Inc. · 2015 · 3 generations on21descendants
- K150230SculpSureCynosure, Inc. · 2015 · 3 generations on21descendants
- K160470SculpSureCynosure, Inc. · 2016 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −2 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −1 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| 0 (this device) | K083629 | Smoothshapes | Eleme Medical, Inc. | 2009 | — |
| +1 | K100230 | Smoothshapes System, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010 | — |
| +2 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +3 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
| +3 | K150230 | SculpSure | Cynosure, Inc. | 2015 | — |
| +4 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K053611 | SmoothshapesSummary page 1…II Product Code NUV CFR section 878.4810 Device panel General & Plastic Surgery Legally marketed {EIem'61sm5b;thShap'es§(K053611; K061603) predicate devices Syneron Velashape (K071872) Elem6 Medical, Inc. Submitter… | 2006 |
| * | K061603 | SmoothshapesSummary page 1…roduct Code NUV CFR section 878.4810 Device panel General & Plastic Surgery Legally marketed {EIem'61sm5b;thShap'es§(K053611; K061603) predicate devices Syneron Velashape (K071872) Elem6 Medical, Inc. Submitter Heron… | 2006 |
| * | K071872 | VelashapeSummary page 1…878.4810 Device panel General & Plastic Surgery Legally marketed {EIem'61sm5b;thShap'es§(K053611; K061603) predicate devices Syneron Velashape (K071872) Elem6 Medical, Inc. Submitter Heron Cove Office Part 10 Al Paul… | 2007 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100230 | Smoothshapes System, 11318-120V, 11319-230V | 2010 | 26 |
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 14 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 3 of the 58 ancestors have a recall of any class.
- Of its descendants, K100230 (Eleme Medical, Inc., 2010) has gone furthest, with 26 descendants of its own.
- 3 other devices also cite its predicate K053611.
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. 2009, 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® 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/K083629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083629: Smoothshapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083629
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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