# K181659: Avologi ENEO

- Pathway: 510(k) (Traditional)
- Applicant: Premier North America, Inc.
- Decided: Jul 26, 2018 after 31 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: 13 generations back to K943450 (1995). 93 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110301: Silk'n FX, Home Skinovations, Ltd. (2011) Summary page 4.
- K152332: Perfectio LED infrared device, Omm Imports Inc Dba Zero Gravity (2016) Summary page 4.

## Most influential descendants
- K213841: ENEO TOTALE (Model: ENEOT947) (2022), 2 descendants of its own
- 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
- K250125: LMNT O2 (2025), 0 descendants of its own

## Indications for use
Avologi ENEO 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/K181659
Methodology: https://510kreport.com/methodology