# K160821: Tria Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Tria Beauty, Inc.
- Decided: Jun 15, 2016 after 83 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 K910422 (1992). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090312: Tria Acne Treatment System, Model Ats-1 Otc, Tria Beauty, Inc. (2010) Summary page 4.

## Indications for use
The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K160821
Methodology: https://510kreport.com/methodology