510(k) · Cleared
ClearedIPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mlay Intelligent Technology Co.,, Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Aug 14, 2025 as substantially equivalent to K241106 (Shenzhen Mlay Intelligent Technology Co.,, Ltd., 2024) and 3 other predicates after a 120-day review. Its family tree reaches back 24 generations to 1995. 1 later device descends from it.
- Decided
- Aug 14, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 24 generations to K950019 (1995). 71 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 24 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 20 generations between
- 3 generations backK220248 Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022
- 2 generations backK240264 Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
- 1 generation backK241106 Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
- This deviceK251176 IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253666 IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd. · 2026
Show all 24 generations
- Root · 24 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 23 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 22 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 21 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 20 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 19 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 18 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 17 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 16 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 15 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 14 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 13 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 12 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 11 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 10 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 9 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 8 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 7 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 6 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- 5 generations backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- 4 generations backK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
- 3 generations backK220248 Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022
- 2 generations backK240264 Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
- 1 generation backK241106 Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
- This deviceK251176 IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −23 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −22 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −21 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −20 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −19 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −18 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −17 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −16 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −15 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −14 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −13 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −12 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −11 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −10 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −9 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −8 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −7 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −6 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| −5 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| −4 | K210311 | Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B… | Shenzhen Mismon Technology Co., Ltd. | 2021 | — |
| −3 | K220248 | Home use hair removal device | Shenzhen Mareal Tech Co., Ltd. | 2022 | — |
| −2 | K240264 | Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A… | Shenzhen Mlay Intelligent Technology Co.,, Ltd. | 2024 | — |
| −1 | K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A… | Shenzhen Mlay Intelligent Technology Co.,, Ltd. | 2024 | — |
| 0 (this device) | K251176 | IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A… | Shenzhen Mlay Intelligent Technology Co.,, Ltd. | 2025 | — |
| +1 | K253666 | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | 2026 | — |
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 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A…Summary page 5…Number Shenzhen Mlay Ice Cooling IPL Home Use Hair Intelligent Removal Device (Model(s):T10B, K241106 April 22, 2024 Technology Co., T10C, T15A, T17A, T18A, Ltd. T14A, T16A, T19A) Intense P… | 2024 |
| * | K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E…Summary page 5…model: T023K, T023A, Science and March 28, T023B, T023C, T023D, T023E, K223928 Technology Co., 2023 T021K, T021A, T001A, T001B, Ltd.… | 2023 |
| * | K242039 | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Summary page 5…Shenzhen Ulike Ice Cooling IPL Hair Removal October 25, Smart Electronics K242039 Device 2024 Co., Ltd. Shenzhen Ulike IPL Hair Removal D… | 2024 |
| * | K230122 | IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGSummary page 5…K242039 Device 2024 Co., Ltd. Shenzhen Ulike IPL Hair Removal Device K230122 January 17, 1 / 13… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | 2026 | 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 30 years and passes through 16 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 71 ancestors has a recall of any class.
- Of its descendants, K253666 (Shenzhen Mlay Intelligent Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
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?
The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair 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/K251176 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251176: IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251176
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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