# K160691: Acne Light Therapy Wand

- Pathway: 510(k) (Traditional)
- Applicant: Zuko, Inc.
- Decided: Jun 21, 2016 after 102 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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). 101 ancestors in all.
50 later devices descend from it; 4 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124042: Tanda Mini Skincare System, Syneron Beauty (2013) Summary page 4.
- K142246: LightStim for Acne/ LightStim for Acne Mini, Led Intellectual Properties, LLC (2015) Summary page 4.

## Most influential descendants
- K210948: Omnilux CLEAR (2021), 39 descendants of its own
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0 (2021), 35 descendants of its own
- K214103: Shani Darden LED light therapy mask (2022), 19 descendants of its own
- K230293: TheraFace Mask (2023), 16 descendants of its own
- K180320: dpl IIa Panel (2018), 14 descendants of its own

## Indications for use
The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K160691
Methodology: https://510kreport.com/methodology