510(k) · Cleared
ClearedMini me
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iluminage Ltd.(Formerly Syneron Beauty Ltd.) · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Dec 19, 2014 as substantially equivalent to K131649 (Syneron Beauty, Ltd., 2013) after a 29-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Dec 19, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K950019 (1995). 47 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 15 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 11 generations between
- 3 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 2 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 1 generation backK131649 MESyneron Beauty, Ltd. · 2013
- This deviceK143339 Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.) · 2014
Show all 15 generations
- Root · 15 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 14 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 13 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 12 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 11 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 10 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 9 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 8 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 7 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 6 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 5 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 4 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 3 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 2 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 1 generation backK131649 MESyneron Beauty, Ltd. · 2013
- This deviceK143339 Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.) · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −14 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −13 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −12 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −11 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −10 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −9 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −8 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −7 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −6 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −5 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −4 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −3 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −2 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −1 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| 0 (this device) | K143339 | Mini me | Iluminage Ltd.(Formerly Syneron Beauty Ltd.) | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K131649 | MESummary page 4…Laser surgical instrument for use in general and plastic surgery and in dermatology Predicate Devices Iluminage Ltd’s (Formerly Syneron Beauty Ltd)- Mē System (K131649) Intended Use / Indications for Use The Mini mē is an over-the counter device intended for the removal of unwanted hair.… | 2013 |
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 19 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 47 ancestors has a recall of any class.
- 1 other device also cites its predicate K131649.
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. 2014, 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 Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143339: Mini me.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143339
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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