510(k) · Cleared
ClearedIPL Cooling Hair Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Siken 3D Technology Development Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Nov 14, 2023 as substantially equivalent to K230097 (Shenzhen Bsx Technology Electronics Co., Ltd., 2023) after a 61-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Nov 14, 2023
- Review
- 61 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K950019 (1995). 58 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 20 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 16 generations between
- 3 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 2 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- 1 generation backK230097 IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103…Shenzhen Bsx Technology Electronics Co., Ltd. · 2023
- This deviceK232845 IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd. · 2023
Show all 20 generations
- Root · 20 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 19 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 18 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 17 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 16 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 15 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 14 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 13 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 12 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 11 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 10 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 9 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 8 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 7 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 6 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 5 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 4 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 3 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 2 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- 1 generation backK230097 IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103…Shenzhen Bsx Technology Electronics Co., Ltd. · 2023
- This deviceK232845 IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −19 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −18 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −17 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −16 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −15 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −14 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −13 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −12 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −11 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −10 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −9 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −8 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −7 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −6 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −5 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −4 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −3 | 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 | K230097 | IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105… | Shenzhen Bsx Technology Electronics Co., Ltd. | 2023 | — |
| 0 (this device) | K232845 | IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K230097 | IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Summary page 5…dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810 III. Predicate Device Predicate device: 510(k) number: K230097 Manufacturer: Shenzhen BSX Technology Electronics Co., Ltd. Trade name: IPL Hair Removal Device, BSXT101 Product c… | 2023 |
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 28 years and passes through 14 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 58 ancestors has a recall of any class.
- 2 other devices also cite its predicate K230097.
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. 2023, 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?
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232845: IPL Cooling 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/K232845
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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