510(k) · Cleared
ClearedME
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Beauty, Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Dec 11, 2013 as substantially equivalent to K123845 (Syneron Beauty, Ltd., 2013) and 5 other predicates after a 189-day review. Its family tree reaches back 14 generations to 1995. 125 later devices descend from it.
- Decided
- Dec 11, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K950019 (1995). 46 ancestors in all, the oldest K892514 (1990). 125 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 10 generations between
- 3 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 2 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 1 generation backK123845 MESyneron Beauty, Ltd. · 2013
- This deviceK131649 MESyneron Beauty, Ltd. · 2013
- Descendant · cites it directly · 123 of its ownK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- Descendant · 2 generations on · 117 of its ownK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- Descendant · 3 generations on · 115 of its ownK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- Descendant · 4 generations on · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- Descendant · 3 generations on · 66 of its ownK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
Show all 14 generations
- Root · 14 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 13 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 12 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 11 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 10 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 9 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 8 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 7 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 6 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 5 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 4 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 3 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 2 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 1 generation backK123845 MESyneron Beauty, Ltd. · 2013
- This deviceK131649 MESyneron Beauty, Ltd. · 2013
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015 · cites it directly123descendants
- K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016 · 2 generations on117descendants
- K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017 · 3 generations on115descendants
- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · 4 generations on88descendants
- K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd. · 2019 · 3 generations on66descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −13 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −12 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −11 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −10 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −9 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −8 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −7 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −6 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −5 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −4 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −3 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −2 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −1 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| 0 (this device) | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| +1 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| +2 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| +3 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| +4 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| +3 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 0 |
| 2023 | 28 | 0 |
| 2024 | 20 | 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 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? (6)
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 |
|---|---|---|---|
| * | K123845 | MESummary page 1…Name ONF- Laser surgical instrument for use in general and plastic surgery and in dermatology, Class 11, 21 CFR 878.48 10 Predicate Devices Syneron Beauty Ltd.'s ma (K 123845; K 12l1598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820;… | 2013 |
| * | K121598 | ME HAIR2GOSummary page 2…al Characteristics There are no technological differences between the me device presented in this submission and the previously cleared versions of the device (K123845, K 121598). The device incorporates Intense Pulse Light (IPL) technology (output 2-4 i/cm 2 ), like other OTC devices for hair removal. The… | 2012 |
| * | K120080 | Shaser HRS2 Hair Removal SystemSummary page 1…plastic surgery and in dermatology, Class 11, 21 CFR 878.48 10 Predicate Devices Syneron Beauty Ltd.'s ma (K 123845; K 12l1598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K120737) Intended Use /Indications for Use… | 2012 |
| * | K103560 | Shaser Ipl Hair Removal SystemSummary page 1…surgery and in dermatology, Class 11, 21 CFR 878.48 10 Predicate Devices Syneron Beauty Ltd.'s ma (K 123845; K 12l1598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K120737) Intended Use /Indications for Use The me i… | 2011 |
| * | K090820 | Tria Hair Removal Laser SystemSummary page 1…icate Devices Syneron Beauty Ltd.'s ma (K 123845; K 12l1598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K120737) Intended Use /Indications for Use The me isan over-the-counter device intended for the removal of unwa… | 2009 |
| * | K120737 | Tria Laser Hair Removal SystemSummary page 1…ices Syneron Beauty Ltd.'s ma (K 123845; K 12l1598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K120737) Intended Use /Indications for Use The me isan over-the-counter device intended for the removal of unwanted hair… | 2012 |
What descends from it? (125)
See all 1252 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 18 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 46 ancestors has a recall of any class.
- Of its descendants, K143003 (Ipulse Limited, 2015) has gone furthest, with 123 descendants of its own.
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. 2013, 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 me is an over-the-counter device intended for the removal of unwanted hair. 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/K131649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131649: ME.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131649
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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