# K232863: Radiant Renewal Skincare Wand (HD-15, HD-15A)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Dec 13, 2023 after 89 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: 16 generations back to K943450 (1995). 165 ancestors in all.
No later device cites it as a predicate yet.
0 of 166 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 5.
- K212342: ZIIP+ Device, Ziip, Inc. (2021) Summary page 5.
- K163470: Galvanic Spa, Model: SKB-1405, Shenzhen Siken 3D Technology Development Co., Ltd. (2017) Summary page 6.
- K202055: Looper (Model: ZX-579S), Heat IN A Click, LLC (2021) Summary page 6.

## Indications for use
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use. The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.

Source page: https://510kreport.com/device/K232863
Methodology: https://510kreport.com/methodology
