# K252845: Venus Nova (FP-2001)

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Inc.
- Decided: Nov 6, 2025 after 59 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K943450 (1995). 242 ancestors in all.
No later device cites it as a predicate yet.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220592: Venus BlissMAX, Venus Concept USA, Inc. (2022) Summary page 5.
- K191528: Venus Legacy Pro Device, Venus Concept USA, Inc. (2019) Summary page 5.

## Indications for use
The Venus Nova device is intended for the treatment of the following medical conditions using the 4D Body (MP2) applicator for delivery of RF energy combined with massage and magnetic field pulses: * Relief of minor muscle aches and pain, relief of muscle spasm * Temporary improvement of local blood circulation * Temporary reduction in the appearance of cellulite When used with the Octipolar (LB1) or Diamondpolar (LFI) applicators, the Venus Nova device is intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV. In addition, the Venus Nova device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus Nova device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Venus Nova device using the FlexMAX applicators is intended to be operated by a trained professional.

Source page: https://510kreport.com/device/K252845
Methodology: https://510kreport.com/methodology