# K180279: Silk'n MODEL H5003 device

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: May 9, 2018 after 98 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: 6 generations back to K010335 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092476: Sport-Elec Body Control System, Model 4M, Sport-Elec (2010) Summary page 4.

## Indications for use
The Silk’n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Source page: https://510kreport.com/device/K180279
Methodology: https://510kreport.com/methodology