# K250532: Solawave 2-in-1 Skincare Mini (Model: 61043)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: May 22, 2025 after 87 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: 15 generations back to K943450 (1995). 95 ancestors in all.
1 later device descends 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)
- K213841: ENEO TOTALE (Model: ENEOT947), Premier North America, Inc. (2022) Summary page 5.

## Most influential descendants
- K252603: HIGHERDOSE Body Sculptor (Model: GS-03) (2026), 0 descendants of its own

## Indications for use
The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.

Source page: https://510kreport.com/device/K250532
Methodology: https://510kreport.com/methodology