# K110888: Absolute White Light

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Fresh, Inc.
- Decided: Jan 12, 2012 after 288 days
- Product code: EEG (Heat Source For Bleaching Teeth)
- Device class: 1
- Regulation: 21 CFR 872.6475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042153 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042153: South Beach Smile Light Whitening System, Dentovations, Inc. (2004)

## Indications for use
The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.

Source page: https://510kreport.com/device/K110888
Methodology: https://510kreport.com/methodology