# K210948: Omnilux CLEAR

- Pathway: 510(k) (Traditional)
- Applicant: Globalmed Technologies
- Decided: Jun 24, 2021 after 86 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: 14 generations back to K943450 (1995). 102 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160691: Acne Light Therapy Wand, Zuko, Inc. (2016) Summary page 6.

## Most influential descendants
- 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
- K230124: LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) (2023), 10 descendants of its own
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023) (2023), 9 descendants of its own

## Indications for use
The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face.

Source page: https://510kreport.com/device/K210948
Methodology: https://510kreport.com/methodology