510(k) · Cleared
ClearediPulse SmoothSkin Gold Hair Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyden Limited · OHT Light Based Over-The-Counter Hair Removal
Cleared on Apr 14, 2016 as substantially equivalent to K143003 (Ipulse Limited, 2015) after an 8-day review. Its family tree reaches back 16 generations to 1995. 117 later devices descend from it.
- Decided
- Apr 14, 2016
- Review
- 8 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K950019 (1995). 50 ancestors in all, the oldest K892514 (1990). 117 later devices descend from it, 27 citing it directly.
- Root · 16 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 12 generations between
- 3 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 2 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 1 generation backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- This deviceK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- Descendant · cites it directly · 115 of its ownK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- Descendant · 2 generations on · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- Descendant · cites it directly · 66 of its ownK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- Descendant · cites it directly · 36 of its ownK173813 IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd. · 2018
- Descendant · 3 generations on · 26 of its ownK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
Show all 16 generations
- Root · 16 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 15 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 14 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 13 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 12 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 11 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 10 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 9 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 8 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 7 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 6 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 5 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 4 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 3 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 2 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 1 generation backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- This deviceK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017 · cites it directly115descendants
- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · 2 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 · cites it directly66descendants
- K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd. · 2018 · cites it directly36descendants
- K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −15 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −14 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −13 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −12 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −11 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −10 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −9 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −8 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −7 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −6 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −5 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −4 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −3 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −2 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −1 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| 0 (this device) | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| +1 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| +2 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| +1 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| +1 | K173813 | IPL Hair Removal Device Joy Version | Shen Zhen Cosbeauty Co., Ltd. | 2018 | — |
| +3 | K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | 2022 | — |
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 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 0 |
| 2023 | 27 | 0 |
| 2024 | 18 | 0 |
| 2025 | 18 | 0 |
| 2026 | 8 | 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 OHT? 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 OHT device
- #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 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 |
|---|---|---|---|
| * | K143003 | iPulse Smooth Skin Gold Hair Removal SystemSummary page 4…and dermatology Device Class: 21 CFR 878.4810 Predicate Device: iPulse SmoothSkin Gold Hair Removal System K143003 CyDen Limited A comparison of the key technological characteristics of the iPulse SmoothSkin Gold… | 2015 |
What descends from it? (117)
See all 11727 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161428 | PerfectSmooth | 2017 | 115 |
| K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 | 2019 | 66 |
| K173813 | IPL Hair Removal Device Joy Version | 2018 | 36 |
| K221002 | IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C | 2022 | 25 |
| K180016 | Home Use IPL Beauty Device | 2018 | 25 |
| K214113 | Hand-held IPL device (JOVS Graphene Hair Removal Device) | 2022 | 22 |
| K190820 | Aimanfun Lumea Comfort | 2019 | 22 |
| K220645 | Hand-held IPL device (JOVS Hair Removal Device) | 2022 | 19 |
| K230122 | IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG | 2023 | 17 |
| K213558 | IPL Hair Removal Device | 2022 | 15 |
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 10 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 50 ancestors has a recall of any class.
- Of its descendants, K161428 (Shen Zhen Cosbeauty Co., Ltd., 2017) has gone furthest, with 115 descendants of its own.
- 5 other devices also cite its predicate K143003.
How does its category compare?
All OHT devicesOHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OHT
25in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHT
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHT
No recall names OHT since 2007.
Adverse event reports per year · OHT
6in 2025
MAUDE reports naming product code OHT, 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 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 81 | 0 | 2 |
| 2017 | 6 | 87 | 0 | 0 |
| 2018 | 8 | 89 | 0 | 0 |
| 2019 | 7 | 64 | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 12 | 89 | 0 | 1 |
| 2022 | 25 | 70 | 0 | 2 |
| 2023 | 32 | 83 | 0 | 6 |
| 2024 | 26 | 62 | 0 | 0 |
| 2025 | 25 | 87 | 0 | 6 |
| 2026 | 11 | 84 | 0 | — |
What is it indicated for?
The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160968: iPulse SmoothSkin Gold Hair Removal Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160968
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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