510(k) · Cleared
ClearedIPL Salon Hair Reduction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · OHT Light Based Over-The-Counter Hair Removal
Cleared on Sep 11, 2018 as substantially equivalent to K161428 (Shen Zhen Cosbeauty Co., Ltd., 2017) and 1 other predicate after an 89-day review. Its family tree reaches back 18 generations to 1995. 88 later devices descend from it.
- Decided
- Sep 11, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K950019 (1995). 56 ancestors in all, the oldest K892514 (1990). 88 later devices descend from it, 9 citing it directly.
- Root · 18 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 14 generations between
- 3 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 2 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 1 generation backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- This deviceK181568 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 · 26 of its ownK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 25 of its ownK221002 IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022
- Descendant · 2 generations on · 24 of its ownK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 23 of its ownK212314 IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2021
Show all 18 generations
- Root · 18 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 17 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 16 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 15 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 14 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 13 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 12 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 11 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 10 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 9 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 8 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 7 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 6 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 5 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 4 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 3 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 2 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 1 generation backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- This deviceK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- 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
- K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022 · cites it directly26descendants
- K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022 · 2 generations on25descendants
- K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd. · 2021 · 2 generations on24descendants
- K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2021 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −17 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −16 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −15 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −14 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −13 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −12 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −11 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −10 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −9 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −8 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −7 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −6 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −5 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −4 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −3 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −2 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −1 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| 0 (this device) | 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 | K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | 2022 | — |
| +2 | K221002 | IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C | Shenzhen Ulike Smart Electronics Co., Ltd. | 2022 | — |
| +2 | K210311 | Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B… | Shenzhen Mismon Technology Co., Ltd. | 2021 | — |
| +2 | K212314 | IPL Hair Removal Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2021 | — |
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 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 10 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 0 |
| 2026 | 7 | 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? (2)
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 |
|---|---|---|---|
| * | K161428 | PerfectSmoothSummary page 5…Primary Predicate Reference Predicate Predicate Type Device Device 510(k) Number K161428 K140631 Regulation 878.4810 878.4810 Number Product Co… | 2017 |
| * | K140631 | Lumena FH Hair Removal SystemSummary page 5…edicate Reference Predicate Predicate Type Device Device 510(k) Number K161428 K140631 Regulation 878.4810 878.4810 Number Product Code OHT… | 2014 |
What descends from it? (88)
See all 889 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 | 2019 | 66 |
| K212318 | IPL Hair Removal | 2022 | 26 |
| K213041 | IPL Hair Removal, Model: OBT-02 | 2021 | 15 |
| K230097 | IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | 2023 | 8 |
| K220669 | IPL HAIR REMOVAL HANDSET, Model: IPL-666 | 2022 | 2 |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini) | 2022 | 1 |
| K222432 | IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439 | 2022 | 0 |
| K212697 | Leaf Smooth | 2021 | 0 |
| K211174 | IPL Hair Removal | 2021 | 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 23 years and passes through 12 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 56 ancestors has a recall of any class.
- Of its descendants, K192432 (Shenzhen Bosidin Technology Co., Ltd., 2019) has gone furthest, with 66 descendants of its own.
- 9 other devices also cite its predicate K161428.
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. 2018, 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 IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181568: IPL Salon Hair Reduction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181568
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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