510(k) · Cleared
ClearedHome Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mismon Technology Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Jul 23, 2021 as substantially equivalent to K180016 (Shenzhen Mismon Technology Co., Ltd., 2018) and 1 other predicate after a 170-day review. Its family tree reaches back 20 generations to 1995. 24 later devices descend from it.
- Decided
- Jul 23, 2021
- Review
- 170 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K950019 (1995). 59 ancestors in all, the oldest K892514 (1990). 24 later devices descend from it, 5 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 backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- This deviceK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
- Descendant · cites it directly · 13 of its ownK220222 IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 12 of its ownK223928 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 8 of its ownK231613 Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B…Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 8 of its ownK220248 Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022
- Descendant · 2 generations on · 6 of its ownK240264 Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
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 backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- This deviceK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd. · 2022 · cites it directly13descendants
- K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2023 · 2 generations on12descendants
- K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2023 · 3 generations on8descendants
- K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022 · cites it directly8descendants
- K240264Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024 · 2 generations on6descendants
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 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K210311 | Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B… | Shenzhen Mismon Technology Co., Ltd. | 2021 | — |
| +1 | K220222 | IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4 | Shenzhen Yuwei Electronic Technology Co., Ltd. | 2022 | — |
| +2 | K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D… | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2023 | — |
| +3 | K231613 | Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G… | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2023 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K180016 | Home Use IPL Beauty DeviceSummary page 4…latory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810 III. Predicate Device The predicate devices are listed as below: 1) Primary: K180016, Home Use IPL Beauty Device/MELSYA-MA, MS-206B, manufactured by Shenzhen Mismon Technology Co., Ltd., and cleared March… | 2018 |
| * | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Summary page 4…1) Primary: K180016, Home Use IPL Beauty Device/MELSYA-MA, MS-206B, manufactured by Shenzhen Mismon Technology Co., Ltd., and cleared March 20, 2018 2) K192432, IPL Home Use Hair Removal Device/D-1128, manufactured by Shenzhen Bosidin Technology Co., Ltd., and cleared November 11,… | 2019 |
What descends from it? (24)
See all 245 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 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, K220222 (Shenzhen Yuwei Electronic Technology Co., Ltd., 2022) has gone furthest, with 13 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. 2021, 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 Home Use IPL Beauty Device is an over-the-counter device intended for 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.
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/K210311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210311: Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210311
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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