# K202780: Sectum

- Pathway: 510(k) (Traditional)
- Applicant: Neauvia North America
- Decided: Jul 30, 2021 after 311 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- 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: 17 generations back to K943450 (1995). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K243223: Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (2026), 0 descendants of its own

## Indications for use
The Sectum control unit is a high frequency generator intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms, increase in local circulation and provide a temporary reduction in the appearance of cellulite. The Sectum control unit utilizes a BODY and PRECISION applicator for delivering high frequency electrotherapy to tissue.

Source page: https://510kreport.com/device/K202780
Methodology: https://510kreport.com/methodology