# K213841: ENEO TOTALE (Model: ENEOT947)

- Pathway: 510(k) (Special)
- Applicant: Premier North America, Inc.
- Decided: Jan 6, 2022 after 28 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 94 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181659: Avologi ENEO, Premier North America, Inc. (2018) Summary page 4.

## Most influential descendants
- K250532: Solawave 2-in-1 Skincare Mini (Model: 61043) (2025), 1 descendant of its own
- K252603: HIGHERDOSE Body Sculptor (Model: GS-03) (2026), 0 descendants of its own

## Indications for use
ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K213841
Methodology: https://510kreport.com/methodology