# K120737: Tria Laser Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Tria Beauty, Inc.
- Decided: Sep 13, 2012 after 188 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: 11 generations back to K950019 (1995). 28 ancestors in all.
130 later devices descend from it; 4 cite it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090820: Tria Hair Removal Laser System, Spectragenics, Inc. (2009) Summary page 1.

## Most influential descendants
- K131649: ME (2013), 125 descendants of its own
- K143003: iPulse Smooth Skin Gold Hair Removal System (2015), 123 descendants of its own
- K160968: iPulse SmoothSkin Gold Hair Removal Device (2016), 117 descendants of its own
- K161428: PerfectSmooth (2017), 115 descendants of its own
- K181568: IPL Salon Hair Reduction System (2018), 88 descendants of its own

## Indications for use
TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Source page: https://510kreport.com/device/K120737
Methodology: https://510kreport.com/methodology