510(k) · Cleared
ClearedIPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C
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 Jun 1, 2022 as substantially equivalent to K160968 (Cyden Limited, 2016) and 2 other predicates after a 58-day review. Its family tree reaches back 20 generations to 1995. 25 later devices descend from it.
- Decided
- Jun 1, 2022
- Review
- 58 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K950019 (1995). 59 ancestors in all, the oldest K892514 (1990). 25 later devices descend from it, 9 citing it directly.
- 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 backK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
- This deviceK221002 IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022
- Descendant · cites it directly · 17 of its ownK230360 IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 11 of its ownK231717 IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003…Foshan Jindi Electric Appliance Co., Ltd. · 2023
- Descendant · cites it directly · 9 of its ownK240016 IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. · 2024
- Descendant · 2 generations on · 6 of its ownK241998 Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024
- Descendant · 2 generations on · 4 of its ownK232499 IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance 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 backK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
- This deviceK221002 IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K230360IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd. · 2023 · cites it directly17descendants
- K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd. · 2023 · 2 generations on11descendants
- K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. · 2024 · cites it directly9descendants
- K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024 · 2 generations on6descendants
- K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd. · 2023 · 2 generations on4descendants
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 | K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K221002 | IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C | Shenzhen Ulike Smart Electronics Co., Ltd. | 2022 | — |
| +1 | 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 | — |
| +2 | K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024 | — |
| +2 | K232499 | IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) | Shenzhen Lescolton Electrical Appliance 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 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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 K230122 IPL Hair Removal Device, Model (s): UI04 SD…score 34.5 · 19 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 |
|---|---|---|---|
| * | K160968 | iPulse SmoothSkin Gold Hair Removal DeviceSummary page 4…0(k) Number Approval Date iPulse SmoothSkin Gold CyDen Limited. K160968 Apr.14, 2016 Hair Removal System Reference devices: Manufacturer… | 2016 |
| * | K173813 | IPL Hair Removal Device Joy VersionSummary page 4…510(k) Number Approval Date Shen Zhen CosBeauty Co., IPL Hair Removal Device K173813 Sept. 07, 2018 Ltd Joy Version, CB-027 Dongguan Define Beauty… | 2018 |
| * | K212318 | IPL Hair RemovalSummary page 4…rsion, CB-027 Dongguan Define Beauty IPL HAIR REMOVAL SG- Electronic Technology Co. K212318 Jan.14, 2022 8025 Ltd IV. Device Description IPL Hair Rem… | 2022 |
What descends from it? (25)
See all 259 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230360 | IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02 | 2023 | 17 |
| K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | 2024 | 9 |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | 2025 | 2 |
| K241205 | Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S… | 2024 | 2 |
| K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A… | 2024 | 2 |
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU… | 2026 | 0 |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU… | 2025 | 0 |
| K240093 | IPL Home Use Hair Removal Device (SJ15) | 2024 | 0 |
| K223524 | IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03 | 2023 | 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 27 years and passes through 14 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 59 ancestors has a recall of any class.
- Of its descendants, K230360 (Shenzhen Jizhimei Technology Co., Ltd., 2023) has gone furthest, with 17 descendants of its own.
- 26 other devices also cite its predicate K160968.
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. 2022, 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 Hair Removal Device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221002
Report an extraction error
Are you the manufacturer?
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