510(k) · Cleared
ClearedTria Fan System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tria Beauty, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Oct 25, 2013 as substantially equivalent to K090525 (Palomar Medical Products, Inc., 2009) and 10 other predicates after a 245-day review. Its family tree reaches back 13 generations to 1992. 1 later device descends from it.
- Decided
- Oct 25, 2013
- Review
- 245 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 13 generations to K910422 (1992). 176 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 1 generation backK090525 Loi SystemPalomar Medical Products, Inc. · 2009
- This deviceK130459 Tria Fan SystemTria Beauty, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK141868 Tria FanpTria Beauty, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 4 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 1 generation backK090525 Loi SystemPalomar Medical Products, Inc. · 2009
- This deviceK130459 Tria Fan SystemTria Beauty, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K141868Tria FanpTria Beauty, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −4 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −3 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −2 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −1 | K090525 | Loi System | Palomar Medical Products, Inc. | 2009 | — |
| 0 (this device) | K130459 | Tria Fan System | Tria Beauty, Inc. | 2013 | — |
| +1 | K141868 | Tria Fanp | Tria Beauty, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 13 | 0 |
| 1996 | 18 | 0 |
| 1997 | 18 | 0 |
| 1998 | 14 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 9 | 0 |
| 2002 | 13 | 0 |
| 2003 | 11 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 ONG? 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 ONG device
- #1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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? (13)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090525 | Loi SystemSummary page 1…fication Name Laser Instrument, Surgical, Powered Regulation Number: 21 CFR§878.4810 Product Code: ONG Predicate Devices Palomar LOI System (K090525) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fi… | 2009 |
| * | K111454 | Iluminage Diode LaserSummary page 1…, Powered Regulation Number: 21 CFR§878.4810 Product Code: ONG Predicate Devices Palomar LOI System (K090525) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K… | 2012 |
| * | K080006 | Affirm with XPL Handpiece and ER:Yag Laser ModuleSummary page 1…4810 Product Code: ONG Predicate Devices Palomar LOI System (K090525) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31… | 2008 |
| Kept off the family tree | K110601 | FDA’s K110601 is Sentinella 102 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | K091420 | Fraxel RE: Store Laser System, Model SR1500Summary page 1…Palomar LOI System (K090525) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria… | 2009 |
| * | K060310 | Fraxel II SR Laser System and AccessoriesSummary page 1…r LOI System (K090525) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is ind… | 2006 |
| * | K063808 | Fraxel IV SR Laser SystemSummary page 1…em (K090525) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is indicated fo… | 2007 |
| * | K062303 | Fraxel II SR Laser SystemSummary page 1…25) Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is indicated for the tre… | 2007 |
| * | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System)Summary page 1…Cynosure luminage Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is indicated for the treatment of… | 2007 |
| * | K050841 | Fraxel SR Laser SystemSummary page 1…age Diode Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is indicated for the treatment of periorbital wri… | 2005 |
| * | K042319 | Reliant Laser II System and AccessoriesSummary page 1…Laser (K1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is indicated for the treatment of periorbital wrinkles, wh… | 2005 |
| * | K040617 | Reliant Laser System IISummary page 1…1 11454) Cynosure Affirm Laser Family (K080006; K1~0601) Solta Fraxel Re:Fine Laser (K091420; K06031 0; K063808; K062303; K070284; K050841; K042319; K040617;K1(31795) Intended Use / Indications for Use Tria FAN is indicated for the treatment of periorbital wrinkles, which may… | 2004 |
| Kept off the family tree | K103795 | FDA’s K103795 is DBX Demineralized Bone Matrix Putty Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141868 | Tria Fanp | 2014 | 0 |
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 21 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 176 ancestors have a recall of any class.
- Of its descendants, K141868 (Tria Beauty, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K090525.
How does its category compare?
All ONG devicesONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONG
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONG
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONG
1in 2025
MAUDE reports naming product code ONG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 4 | 176 | 1 | 3 |
| 2011 | 6 | 122 | 0 | 2 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 3 | 243 | 0 | 4 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 40 |
| 2018 | 2 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 3 | 203 | 0 | 2 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 2 | 11 |
| 2025 | 4 | 97 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Tria FAN is indicated for the treatment of periarbital wrinkles, which may result in smoother appearing skin in the treated area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130459: Tria Fan System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130459
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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