# K090399: Trios System

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Jun 10, 2009 after 113 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 11 generations back to K910422 (1992). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072331: Radiancy Mistral Device, Radiancy (Israel), Ltd. (2008) Summary page 2.
- K050165: Modification to Ifl Professional System, Model C100, Cyden Limited (2005) Summary page 2.
- K060234: Mccue Energist Ultra VPL Intense Pulse Light System, Mccue Plc (2006) Summary page 2.
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems, Lumenis (2003) Summary page 2.

## Indications for use
The TriosTM system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K090399
Methodology: https://510kreport.com/methodology