510(k) · Cleared
ClearedTria Hair Removal Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectragenics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 23, 2009 as substantially equivalent to K053527 (Spectragenics, Inc., 2008) and 2 other predicates after a 272-day review. Its family tree reaches back 10 generations to 1995. 167 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 272 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K950019 (1995). 27 ancestors in all. 167 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 6 generations between
- 3 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 2 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 1 generation backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- This deviceK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- Descendant · cites it directly · 148 of its ownK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- Descendant · cites it directly · 140 of its ownK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
- Descendant · 2 generations on · 135 of its ownK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- Descendant · cites it directly · 130 of its ownK120737 Tria Laser Hair Removal SystemTria Beauty, Inc. · 2012
- Descendant · cites it directly · 127 of its ownK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
Show all 10 generations
- Root · 10 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 9 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 8 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 7 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 6 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 5 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 4 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 3 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 2 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 1 generation backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- This deviceK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · See all- K103184Silk'n Flash N GOHome Skinovations, Ltd. · 2010 · cites it directly148descendants
- K103560Shaser Ipl Hair Removal SystemShaser, Inc. · 2011 · cites it directly140descendants
- K120080Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012 · 2 generations on135descendants
- K120737Tria Laser Hair Removal SystemTria Beauty, Inc. · 2012 · cites it directly130descendants
- K121598ME HAIR2GOSyneron Medical, Ltd. · 2012 · cites it directly127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −9 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −8 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −7 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −6 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −5 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −4 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −3 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −2 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −1 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| 0 (this device) | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| +1 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| +1 | K103560 | Shaser Ipl Hair Removal System | Shaser, Inc. | 2011 | — |
| +2 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| +1 | K120737 | Tria Laser Hair Removal System | Tria Beauty, Inc. | 2012 | — |
| +1 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 22 | 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? (3)
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 |
|---|---|---|---|
| * | K053527 | Spectra Hair Removal LaserSummary page 1…nt, Surgical, Powered Regulation Number: 21 C.F.R. § 878.48 10 Product Code: GEX Predicate Devices SpectraGenies Spectra Hair Removal Laser System (K053527) Star Medical Technologies LightSheer Pulsed Diode Array Laser System (K982940) Home Skinovations Flash N' Go (K082… | 2008 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…ode: GEX Predicate Devices SpectraGenies Spectra Hair Removal Laser System (K053527) Star Medical Technologies LightSheer Pulsed Diode Array Laser System (K982940) Home Skinovations Flash N' Go (K082298) Intended Use I Indications for Use TRIA is an over-the-co… | 1999 |
| * | K082298 | Flash N' GOSummary page 1…s Spectra Hair Removal Laser System (K053527) Star Medical Technologies LightSheer Pulsed Diode Array Laser System (K982940) Home Skinovations Flash N' Go (K082298) Intended Use I Indications for Use TRIA is an over-the-counter device intended for adjunctive use with s… | 2008 |
What descends from it? (167)
See all 1677 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 14 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K103184 (Home Skinovations, Ltd., 2010) has gone furthest, with 148 descendants of its own.
- 1 other device also cites its predicate K053527.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090820 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090820: Tria Hair Removal Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090820
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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