510(k) · Cleared
ClearedTria Laser Hair Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tria Beauty, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 13, 2012 as substantially equivalent to K090820 (Spectragenics, Inc., 2009) after a 188-day review. Its family tree reaches back 11 generations to 1995. 130 later devices descend from it.
- Decided
- Sep 13, 2012
- Review
- 188 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K950019 (1995). 28 ancestors in all. 130 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 7 generations between
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK120737 Tria Laser Hair Removal SystemTria Beauty, Inc. · 2012
- Descendant · cites it directly · 125 of its ownK131649 MESyneron Beauty, Ltd. · 2013
- Descendant · 2 generations on · 123 of its ownK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- Descendant · 3 generations on · 117 of its ownK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- Descendant · 4 generations on · 115 of its ownK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- Descendant · 5 generations on · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
Show all 11 generations
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 10 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 9 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 8 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 7 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 6 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 5 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 4 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK120737 Tria Laser Hair Removal SystemTria Beauty, Inc. · 2012
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K131649MESyneron Beauty, Ltd. · 2013 · cites it directly125descendants
- K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015 · 2 generations on123descendants
- K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016 · 3 generations on117descendants
- K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017 · 4 generations on115descendants
- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · 5 generations on88descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −10 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −9 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −8 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −7 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −6 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −5 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −4 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −3 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −2 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −1 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| 0 (this device) | K120737 | Tria Laser Hair Removal System | Tria Beauty, Inc. | 2012 | — |
| +1 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| +2 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| +3 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| +4 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| +5 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 14 | 0 |
| 2022 | 24 | 0 |
| 2023 | 28 | 0 |
| 2024 | 21 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090820 | Tria Hair Removal Laser SystemSummary page 1…Laser Instrument, Surgical, Powered Regulation Number: 21 C.F.R.§ 878.4810 Product Code: SEX Predicate Devices TRIA Laser Hair Removal System (K090820) Intended Use I Indications for Use TRIA is an over-the-counter device intended for adjunctive use with s… | 2009 |
What descends from it? (130)
See all 1304 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K131649 (Syneron Beauty, Ltd., 2013) has gone furthest, with 125 descendants of its own.
- 6 other devices also cite its predicate K090820.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120737: Tria Laser Hair Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120737
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026