# K113724: Electropulse-Cosmetic

- Pathway: 510(k) (Traditional)
- Applicant: Pain Relief Technologies
- Decided: Feb 15, 2012 after 58 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device Is Indicated for cosmetic use. Infrared Light and Heat: Eimis energy in the near-JR spectrum for temporarily Promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted

Source page: https://510kreport.com/device/K113724
Methodology: https://510kreport.com/methodology