510(k) · Cleared
ClearedCutera Multimodal Cellulite Product (Cmmcd)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Apr 8, 2008 as substantially equivalent to K050397 (Syneron Medical, Ltd., 2005) and 4 other predicates after a 63-day review. Its family tree reaches back 14 generations to 1995. 101 later devices descend from it.
- Decided
- Apr 8, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K943450 (1995). 57 ancestors in all, the oldest K800617 (1980). 101 later devices descend from it, 2 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 backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 1 generation backK071872 VelashapeSyneron Medical, Ltd. · 2007
- This deviceK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- Descendant · cites it directly · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · cites it directly · 45 of its ownK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- Descendant · 2 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 3 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 2 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
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 backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 1 generation backK071872 VelashapeSyneron Medical, Ltd. · 2007
- This deviceK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K090221Reaction SystemViora, Ltd. · 2009 · cites it directly54descendants
- K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009 · cites it directly45descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 2 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 3 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 2 generations on31descendants
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 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| −1 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| 0 (this device) | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| +1 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +1 | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| +2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +2 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 15 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K050397 | Velasmooth, ShaperSummary page 1…n dermatology). The Product Code is NUV. Common Name: Massager, Vacuum, Light Induced Heating III. Predicate Devices * K050397 Velasmooth manufactured by Syneron Medical Ltd. * K070092 Velasmooth manufactured by Syneron Medical Ltd… | 2005 |
| * | K070092 | Modification to Velasmooth, ShaperSummary page 1…Massager, Vacuum, Light Induced Heating III. Predicate Devices * K050397 Velasmooth manufactured by Syneron Medical Ltd. * K070092 Velasmooth manufactured by Syneron Medical Ltd * K071872 Velashape manufactured by Syneron Medical Ltd… | 2007 |
| * | K071872 | VelashapeSummary page 1…ate Devices * K050397 Velasmooth manufactured by Syneron Medical Ltd. * K070092 Velasmooth manufactured by Syneron Medical Ltd * K071872 Velashape manufactured by Syneron Medical Ltd * K030876 Triactive manufactured by Cynosure Corporation… | 2007 |
| * | K030876 | Cynosure Triactive Therapeutic Massage SystemSummary page 1…n Medical Ltd. * K070092 Velasmooth manufactured by Syneron Medical Ltd * K071872 Velashape manufactured by Syneron Medical Ltd * K030876 Triactive manufactured by Cynosure Corporation * K990445 LPG Therapeutic Massager by LPG Systems IV. Prod… | 2004 |
| * | K990445 | LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorSummary page 1…on Medical Ltd * K071872 Velashape manufactured by Syneron Medical Ltd * K030876 Triactive manufactured by Cynosure Corporation * K990445 LPG Therapeutic Massager by LPG Systems IV. Product Description/Technological Characteristics The Cutera CMMCD t… | 2000 |
What descends from it? (101)
See all 1012 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.
- 3 of the 57 ancestors have a recall of any class.
- Of its descendants, K090221 (Viora, Ltd., 2009) has gone furthest, with 54 descendants of its own.
- 7 other devices also cite its predicate K050397.
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. 2008, 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 Cutera CMMCD infrared and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080300: Cutera Multimodal Cellulite Product (Cmmcd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080300
Report an extraction error
Are you the manufacturer?
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