# K252187: Aura Glide  (FC40)

- Pathway: 510(k) (Traditional)
- Applicant: Aura Medical, LLC
- Decided: Dec 23, 2025 after 162 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: 15 generations back to K943450 (1995). 154 ancestors in all.
No later device cites it as a predicate yet.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171821: 2 Face / Face Evolution, Heat IN A Click (2018) Summary page 6.

## Indications for use
The Aura Glide is an over-the-counter handheld device for aesthetic purposes. (1) The microcurrent mode is indicated for facial stimulation. (2) The LED mode is intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate inflammatory acne (blue light).

Source page: https://510kreport.com/device/K252187
Methodology: https://510kreport.com/methodology