# K081307: Omnilux Clear-U

- Pathway: 510(k) (Traditional)
- Applicant: Photo Therapeutics, Inc.
- Decided: Jan 16, 2009 after 253 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: 9 generations back to K943450 (1995). 86 ancestors in all.
169 later devices descend from it; 9 cite it directly.
0 of 256 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.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K043329: Omnilux Revive and Blue, Photo Therapeutics Limited (2005) Summary page 1.

## Most influential descendants
- K121435: Silkn Blue (2013), 125 descendants of its own
- K123999: Illumask Acne Light Therapy Mask (2013), 112 descendants of its own
- K140471: Pro X Otc 5 (2015), 107 descendants of its own
- K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (2017), 106 descendants of its own
- K170984: LG Beauty Led Mask (2017), 93 descendants of its own

## Indications for use
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face

Source page: https://510kreport.com/device/K081307
Methodology: https://510kreport.com/methodology