# K191528: Venus Legacy Pro Device

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Sep 6, 2019 after 88 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: 18 generations back to K943450 (1995). 112 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142910: Legacy BX, Venus Concept USA, Inc. (2014) Summary page 4.
- K143554: Venus Legacy CX, Venus Concept, Ltd. (2015) Summary page 4.

## Most influential descendants
- K220592: Venus BlissMAX (2022), 1 descendant of its own
- K252845: Venus Nova (FP-2001) (2025), 0 descendants of its own
- K231092: T-Shape 2 (2023), 0 descendants of its own

## Indications for use
When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro 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. When used with the 4D Body (LB2) or 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions: • Relief of minor muscles aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite

Source page: https://510kreport.com/device/K191528
Methodology: https://510kreport.com/methodology