510(k) · Cleared
ClearedHome Use Hair Removal Device/T1, T2, T3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mareal Tech Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Feb 12, 2018 as substantially equivalent to K161428 (Shen Zhen Cosbeauty Co., Ltd., 2017) and 1 other predicate after a 144-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Feb 12, 2018
- Review
- 144 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K950019 (1995). 52 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 18 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 14 generations between
- 3 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 2 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 1 generation backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- This deviceK172883 Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd. · 2018
Show all 18 generations
- Root · 18 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 17 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 16 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 15 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 14 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 13 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 12 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 11 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 10 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 9 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 8 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 7 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 6 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 5 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 4 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 3 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 2 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 1 generation backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- This deviceK172883 Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −17 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −16 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −15 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −14 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −13 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −12 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −11 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −10 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −9 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −8 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −7 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −6 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −5 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −4 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −3 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −2 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −1 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| 0 (this device) | K172883 | Home Use Hair Removal Device/T1, T2, T3 | Shenzhen Mareal Tech Co., Ltd. | 2018 | — |
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 | 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? (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 |
|---|---|---|---|
| * | K161428 | PerfectSmoothSummary page 4…Predicate Device 510(k) Number Approval Date Shen Zhen CosBeauty Perfectsmooth K161428 March 23, 2017 Co., Ltd iPulse SmoothSkin Gold Hair CyDen Limited… | 2017 |
| * | K160968 | iPulse SmoothSkin Gold Hair Removal DeviceSummary page 4…K161428 March 23, 2017 Co., Ltd iPulse SmoothSkin Gold Hair CyDen Limited K160968 April 04, 2016 Removal System 2） No reference devices were used in this su… | 2016 |
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 23 years and passes through 12 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 52 ancestors has a recall of any class.
- 9 other devices also cite its predicate K161428.
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. 2018, 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 Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172883 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172883: Home Use Hair Removal Device/T1, T2, T3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172883
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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