510(k) · Cleared
ClearedReaction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viora, Ltd. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Jul 1, 2009 as substantially equivalent to K071872 (Syneron Medical, Ltd., 2007) and 5 other predicates after a 152-day review. Its family tree reaches back 15 generations to 1995. 54 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 152 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K943450 (1995). 64 ancestors in all, the oldest K800617 (1980). 54 later devices descend from it, 7 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 2 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 1 generation backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- This deviceK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · cites it directly · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 2 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · cites it directly · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 2 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- Descendant · cites it directly · 17 of its ownK143554 Venus Legacy CXVenus Concept, Ltd. · 2015
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 backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 2 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 1 generation backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- This deviceK090221 Reaction SystemViora, Ltd. · 2009
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K133837Viora V-TotalViora, Ltd. · 2014 · cites it directly33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 2 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · cites it directly31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 2 generations on18descendants
- K143554Venus Legacy CXVenus Concept, Ltd. · 2015 · cites it directly17descendants
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 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| −2 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| −1 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| 0 (this device) | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +1 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +2 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +1 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +2 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| +1 | K143554 | Venus Legacy CX | Venus Concept, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 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 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K071872 | VelashapeSummary page 2…age 2 === 5-2 o: VIORA Predicate Device: VelaShape from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 5 10(k) # K071872; VelaSmooth, Shaper from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K050397; LPG Therapeutic Massager fro… | 2007 |
| * | K050397 | Velasmooth, ShaperSummary page 2…m Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 5 10(k) # K071872; VelaSmooth, Shaper from Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K050397; LPG Therapeutic Massager from LPG USA Inc, Fort Lauderdale, Fl, USA, cleared under 510(k) # K990445 and Description of the devi… | 2005 |
| * | K990445 | LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorSummary page 2…m Syneron Medical Ltd, Yokneam Elite, Israel, cleared under 510(k) # K050397; LPG Therapeutic Massager from LPG USA Inc, Fort Lauderdale, Fl, USA, cleared under 510(k) # K990445 and Description of the device: The ReactionTM system combines CORETM (Channeling Optimized RF Energy) technology with mechanical… | 2000 |
| * | K080300 | Cutera Multimodal Cellulite Product (Cmmcd)Summary page 3…em has the samne intended use and the same perfbrmancecharacteristics as the RF application of( utera CMMCD from Cutera Inc in Brisbn, C(A, LISA, cleared under. 510(k) # K080300 and: the follow ing predicafc devices: Intelect®'SWID 100/ Senior Solutions fr-om Chattanooga Gioup in. IHxson, TN., USA. cleared… | 2008 |
| * | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 Cleared while this submission was under review Summary page 3…under. 510(k) # K080300 and: the follow ing predicafc devices: Intelect®'SWID 100/ Senior Solutions fr-om Chattanooga Gioup in. IHxson, TN., USA. cleared under 5.10(k) K083433 and Auto*Therm(®)390, Model ME 390 firom Mettlier iectiolics Corp in Anaheim, CA, UqSA, cleared under 5'1 0(k.) e#K042554.… | 2009 |
| * | K042554 | Auto Therm 390, Model ME 390Summary page 3…p in. IHxson, TN., USA. cleared under 5.10(k) K083433 and Auto*Therm(®)390, Model ME 390 firom Mettlier iectiolics Corp in Anaheim, CA, UqSA, cleared under 5'1 0(k.) e#K042554. atian System is thmtefbre substantiall.y equivalent to those.dexvices :1h Re ti for each ot (he intended appIications.… | 2004 |
What descends from it? (54)
See all 547 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 14 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 4 of the 64 ancestors have a recall of any class.
- Of its descendants, K133837 (Viora, Ltd., 2014) has gone furthest, with 33 descendants of its own.
- 6 other devices also cite its predicate K071872.
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 Reaction TM system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators for delivering non thermal RF combined with massage:
- relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and
- temporary reduction in the appearance of cellulite.
Using the ST applicator for delivering RF, the Reaction TM system is intended for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090221: Reaction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090221
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