# K090221: Reaction System

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Jul 1, 2009 after 152 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 64 ancestors in all.
54 later devices descend from it; 7 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071872: Velashape, Syneron Medical, Ltd. (2007) Summary page 2.
- K050397: Velasmooth, Shaper, Syneron Medical, Ltd. (2005) Summary page 2.
- K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator, Lpg USA, Inc. (2000) Summary page 2.
- K080300: Cutera Multimodal Cellulite Product (Cmmcd), Cutera, Inc. (2008) Summary page 3.
- K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601, Chattanooga Group (2009). Cleared while this submission was under review Summary page 3.
- K042554: Auto Therm 390, Model ME 390, Mettler Electronics Corp. (2004) Summary page 3.

## Most influential descendants
- K133837: Viora V-Total (2014), 33 descendants of its own
- K142093: V20 System (2014), 32 descendants of its own
- K150035: V10 system (2015), 31 descendants of its own
- K153568: InMode Plus System (2016), 18 descendants of its own
- K143554: Venus Legacy CX (2015), 17 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K090221
Methodology: https://510kreport.com/methodology