# K120511: Ageless Wonder Facial Muscle Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Leto Enterprise, Ltd.
- Decided: Jul 30, 2012 after 160 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
Longest line of descent: 2 generations back to K011935 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072260: Nuface, Model NU-4003, Carol Cole Company (2007) Summary page 2.

## Most influential descendants
- K220198: Medi Lift PLUS (2023), 3 descendants of its own
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (2026), 0 descendants of its own
- K250618: Medi Lift Essential Eye Mask (2025), 0 descendants of its own
- K244048: Medi Lift Mask (2025), 0 descendants of its own

## Indications for use
Ageless Wonder Facial Muscle Stimulation System is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

Source page: https://510kreport.com/device/K120511
Methodology: https://510kreport.com/methodology