# K090312: Tria Acne Treatment System, Model Ats-1 Otc

- Pathway: 510(k) (Traditional)
- Applicant: Tria Beauty, Inc.
- Decided: Jan 5, 2010 after 333 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 8 generations back to K910422 (1992). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060567: Spectragenics Ats-1, Spectragenics, Inc. (2006) Summary page 1.
- K060653: Thermaclear, Dermacare, Inc. (2006) Summary page 1.
- K043377: ZENO, Tyrell, Inc. (2005) Summary page 1.
- K080591: Tanda Skincare System, Model: Ptscs, Pharos Life Corporation (2008) Summary page 1.

## Most influential descendants
- K160821: Tria Sapphire (2016), 0 descendants of its own

## Indications for use
The TRIA Beauty ATS-1I OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K090312
Methodology: https://510kreport.com/methodology