510(k) · Cleared
ClearedTrios System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viora, Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Jun 10, 2009 as substantially equivalent to K072331 (Radiancy (Israel), Ltd., 2008) and 3 other predicates after a 113-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Jun 10, 2009
- Review
- 113 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K910422 (1992). 85 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 2 generations backK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- 1 generation backK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- This deviceK090399 Trios SystemViora, Ltd. · 2009
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 6 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 5 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 4 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 3 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 2 generations backK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- 1 generation backK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- This deviceK090399 Trios SystemViora, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −6 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −4 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −3 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| −2 | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| −1 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| 0 (this device) | K090399 | Trios System | Viora, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K072331 | Radiancy Mistral DeviceSummary page 2…5-2 VIORA Predicate Device: Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331; IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pul… | 2008 |
| * | K050165 | Modification to Ifl Professional System, Model C100Summary page 2…tral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331; IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 5 10(k) # K060234 and Lumeni… | 2005 |
| * | K060234 | Mccue Energist Ultra VPL Intense Pulse Light SystemSummary page 2…en Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 5 10(k) # K060234 and Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527 Description of the devi… | 2006 |
| * | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsSummary page 2…System from McCue PLC, Southhampton, UK, cleared under 5 10(k) # K060234 and Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527 Description of the device: The use of TriosTM in aesthetic applications is based on the principle of Selective Photothermolysis.… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 85 ancestors has a recall of any class.
- 1 other device also cites its predicate K072331.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TriosTM system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090399: Trios System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090399
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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