510(k) · Cleared
ClearedVelasmooth, Shaper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Medical, Ltd. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Jun 9, 2005 as substantially equivalent to K990445 (Lpg USA, Inc., 2000) and 4 other predicates after a 113-day review. Its family tree reaches back 11 generations to 1995. 150 later devices descend from it.
- Decided
- Jun 9, 2005
- Review
- 113 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K943450 (1995). 53 ancestors in all, the oldest K800617 (1980). 150 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK030142 Thermacool TC SystemThermage, Inc. · 2003
- This deviceK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- Descendant · cites it directly · 128 of its ownK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- Descendant · cites it directly · 127 of its ownK071872 VelashapeSyneron Medical, Ltd. · 2007
- Descendant · cites it directly · 101 of its ownK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- Descendant · cites it directly · 95 of its ownK053611 SmoothshapesBicellulase, Inc. · 2006
- Descendant · cites it directly · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 6 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 5 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 4 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK030142 Thermacool TC SystemThermage, Inc. · 2003
- This deviceK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
Showing 5 of 150 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 150 · See all- K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007 · cites it directly128descendants
- K071872VelashapeSyneron Medical, Ltd. · 2007 · cites it directly127descendants
- K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008 · cites it directly101descendants
- K053611SmoothshapesBicellulase, Inc. · 2006 · cites it directly95descendants
- K090221Reaction SystemViora, Ltd. · 2009 · cites it directly54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −6 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −5 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −4 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −3 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −1 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| 0 (this device) | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| +1 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| +1 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| +1 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| +1 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| +1 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 14 | 0 |
| 2017 | 10 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 12 | 0 |
| 2025 | 18 | 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 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? (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 |
|---|---|---|---|
| * | K990445 | LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorSummary page 1…combination of the following devices: LPG therapeutic massager, manufactured by LPG systems and subject of K990445. WS-501 Heat lamp, manufactured by Lhasa Medical Inc. and subject of K013197. TDP CQ-27 heat lamp,… | 2000 |
| * | K013197 | WS-501 Heat LampSummary page 1…ager, manufactured by LPG systems and subject of K990445. WS-501 Heat lamp, manufactured by Lhasa Medical Inc. and subject of K013197. TDP CQ-27 heat lamp, manufactured by Lhasa Medical, Inc. and subject of K003538. Aur… | 2002 |
| * | K003538 | TDP CQ-27 Heat LampSummary page 1…actured by Lhasa Medical Inc. and subject of K013197. TDP CQ-27 heat lamp, manufactured by Lhasa Medical, Inc. and subject of K003538. Aurora DS, manufactured by Syneron medical Ltd. and subject of K03 1988. ThermaCool… | 2001 |
| * | K031988 | Aurora DSSummary page 1…manufactured by Lhasa Medical, Inc. and subject of K003538. Aurora DS, manufactured by Syneron medical Ltd. and subject of K03 1988. ThermaCool 'rC, manufactured by Thermage Inc. and subject of KO3Ol42. DcviceDescription: The Vela smooth,… | 2003 |
| * | K030142 | Thermacool TC System | 2003 |
What descends from it? (150)
See all 1508 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070092 | Modification to Velasmooth, Shaper | 2007 | 128 |
| K071872 | Velashape | 2007 | 127 |
| K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | 2008 | 101 |
| K053611 | Smoothshapes | 2006 | 95 |
| K090221 | Reaction System | 2009 | 54 |
| K061603 | Smoothshapes | 2006 | 48 |
| K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | 2009 | 45 |
| K090580 | Thermage Thermacool NXT System and Accessories | 2009 | 19 |
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 10 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 3 of the 53 ancestors have a recall of any class.
- Of its descendants, K070092 (Syneron Medical, Ltd., 2007) has gone furthest, with 128 descendants of its own.
- 6 other devices also cite its predicate K990445.
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.
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?
Vela smooth, Shaper is indicated for the relief of minor muscle aches and pain. Relief of muscle spasm. Temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050397 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050397: Velasmooth, Shaper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050397
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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