# K213748: CoreLevee

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Oct 14, 2022 after 318 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K062439 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180813: BTL 799-2, BTL Industries, Inc. (2018) Summary page 4.

## Indications for use
CoreLevée is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of buttocks and thighs.

Source page: https://510kreport.com/device/K213748
Methodology: https://510kreport.com/methodology