# K132613: Sonilase Light Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Biorenew Labs, LLC
- Decided: Feb 5, 2014 after 168 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.

## Most influential descendants
- K171647: BeneLife Premium Facial Treatment Pack, Model: QZ0701A (2017), 0 descendants of its own

## Indications for use
The SonilaseTM Light Device Red is used to treat periorbital wrinkles and fine lines around the eyes (i.e., crow's feet).

Source page: https://510kreport.com/device/K132613
Methodology: https://510kreport.com/methodology