# K130459: Tria Fan System

- Pathway: 510(k) (Traditional)
- Applicant: Tria Beauty, Inc.
- Decided: Oct 25, 2013 after 245 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 13 generations back to K910422 (1992). 176 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090525: Loi System, Palomar Medical Products, Inc. (2009) Summary page 1.
- K111454: Iluminage Diode Laser, Cynosure, Inc. (2012) Summary page 1.
- K080006: Affirm with XPL Handpiece and ER:Yag Laser Module, Cynosure, Inc. (2008) Summary page 1.
- K091420: Fraxel RE: Store Laser System, Model SR1500, Solta Medical, Inc. (2009) Summary page 1.
- K060310: Fraxel II SR Laser System and Accessories, Reliant Technologies, Inc. (2006) Summary page 1.
- K063808: Fraxel IV SR Laser System, Reliant Technologies, Inc. (2007) Summary page 1.
- K062303: Fraxel II SR Laser System, Reliant Technologies, Inc. (2007) Summary page 1.
- K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System), Reliant Technologies, Inc. (2007) Summary page 1.
- K050841: Fraxel SR Laser System, Reliant Technologies, Inc. (2005) Summary page 1.
- K042319: Reliant Laser II System and Accessories, Reliant Technologies, Inc. (2005) Summary page 1.
- K040617: Reliant Laser System II, Reliant Technologies, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K110601: Sentinella 102, General Equipment For Medical Imaging, S.A. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K103795: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141868: Tria Fanp (2014), 0 descendants of its own

## Indications for use
Tria FAN is indicated for the treatment of periarbital wrinkles, which may result in smoother appearing skin in the treated area.

Source page: https://510kreport.com/device/K130459
Methodology: https://510kreport.com/methodology