# K161849: Bright

- Pathway: 510(k) (Special)
- Applicant: Tanda Beauty Canada, Inc.
- Decided: Jul 29, 2016 after 24 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: 1 generation back to K110735 (2011). 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)
- K110735: Tanda Max Otc System, Pharos Life Corporation (2011) Summary page 4.

## Indications for use
The Bright device is intended to be used for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

Source page: https://510kreport.com/device/K161849
Methodology: https://510kreport.com/methodology