# K132518: Nubrilliance Pulsed Light Hair Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Wellquest Intl., Inc.
- Decided: Aug 17, 2014 after 370 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- 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: 12 generations back to K950019 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103184: Silk'n Flash N GO, Home Skinovations, Ltd. (2010) Summary page 5.

## Indications for use
The Wellquest NuBrilliance Pulsed Light Hair Removal system device is an over-the-counter device intended for the removal of unwanted hair. The NuBrilliance Pulsed Light Hair Removal System is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of the treatment regimen.

Source page: https://510kreport.com/device/K132518
Methodology: https://510kreport.com/methodology