510(k) · Cleared
ClearedIce Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ulike Smart Electronics Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on May 23, 2025 as substantially equivalent to K242039 (Shenzhen Ulike Smart Electronics Co., Ltd., 2024) and 2 other predicates after a 56-day review. Its family tree reaches back 26 generations to 1995.
- Decided
- May 23, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 26 generations to K950019 (1995). 74 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 26 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 22 generations between
- 3 generations backK230360 IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd. · 2023
- 2 generations backK231717 IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003…Foshan Jindi Electric Appliance Co., Ltd. · 2023
- 1 generation backK240016 IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. · 2024
- This deviceK250938 Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025
Show all 26 generations
- Root · 26 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 25 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 24 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 23 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 22 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 21 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 20 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 19 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 18 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 17 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 16 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 15 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 14 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 13 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 12 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 11 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 10 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 9 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 8 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- 7 generations backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- 6 generations backK212314 IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2021
- 5 generations backK214113 Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd. · 2022
- 4 generations backK220645 Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd. · 2022
- 3 generations backK230360 IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd. · 2023
- 2 generations backK231717 IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003…Foshan Jindi Electric Appliance Co., Ltd. · 2023
- 1 generation backK240016 IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. · 2024
- This deviceK250938 Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −25 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −24 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −23 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −22 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −21 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −20 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −19 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −18 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −17 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −16 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −15 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −14 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −13 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −12 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −11 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −10 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −9 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −8 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| −7 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| −6 | K212314 | IPL Hair Removal Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2021 | — |
| −5 | K214113 | Hand-held IPL device (JOVS Graphene Hair Removal Device) | Shenzhen Qianyu Technology Co., Ltd. | 2022 | — |
| −4 | K220645 | Hand-held IPL device (JOVS Hair Removal Device) | Shenzhen Qianyu Technology Co., Ltd. | 2022 | — |
| −3 | K230360 | IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02 | Shenzhen Jizhimei Technology Co., Ltd. | 2023 | — |
| −2 | K231717 | IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012… | Foshan Jindi Electric Appliance Co., Ltd. | 2023 | — |
| −1 | K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | Shenzhen Jianrong Biomedical Electronics Co., Ltd. | 2024 | — |
| 0 (this device) | K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025 | — |
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 | 4 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K242039 | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Summary page 5…Predicate Device Predicate Device 1 Predicate Device 2 Predicate Device 3 510(k) number K242039 K130315 K240016 Shenzhen Ulike Smart Electronics Co., Ltd.… | 2024 |
| * | K130315 | Ipulse Hair Removal SystemSummary page 5…Predicate Device Predicate Device 1 Predicate Device 2 Predicate Device 3 510(k) number K242039 K130315 K240016 Shenzhen Ulike Smart Electronics Co., Ltd. Trade Name… | 2013 |
| * | K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04)Summary page 5…vice Predicate Device 1 Predicate Device 2 Predicate Device 3 510(k) number K242039 K130315 K240016 Shenzhen Ulike Smart Electronics Co., Ltd. Trade Name Ice… | 2024 |
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 30 years and passes through 19 companies; a new generation was cleared every 11 months on median.
- 1 of the 74 ancestors has a recall of any class.
- 4 other devices also cite its predicate K242039.
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. 2025, 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?
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device 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/K250938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250938: Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250938
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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