# K072459: Omnilux New-U

- Pathway: 510(k) (Traditional)
- Applicant: Photo Therapeutics, Inc.
- Decided: Mar 3, 2008 after 185 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: 10 generations back to K943450 (1995). 90 ancestors in all.
91 later devices descend from it; 6 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.
- K050216: Omnilux Revive and Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 2.

## Most influential descendants
- K110301: Silk'n FX (2011), 66 descendants of its own
- K152332: Perfectio LED infrared device (2016), 61 descendants of its own
- K162489: RED Light Device (2017), 55 descendants of its own
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own

## Indications for use
The Omnilux New-U is intended 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/K072459
Methodology: https://510kreport.com/methodology