510(k) · Cleared
ClearedPerfectSmooth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shen Zhen Cosbeauty Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Mar 23, 2017 as substantially equivalent to K160968 (Cyden Limited, 2016) after a 304-day review. Its family tree reaches back 17 generations to 1995. 115 later devices descend from it.
- Decided
- Mar 23, 2017
- Review
- 304 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K950019 (1995). 51 ancestors in all, the oldest K892514 (1990). 115 later devices descend from it, 10 citing it directly.
- Root · 17 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 13 generations between
- 3 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 2 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 1 generation backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- This deviceK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- Descendant · cites it directly · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- Descendant · cites it directly · 66 of its ownK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- Descendant · cites it directly · 36 of its ownK173813 IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd. · 2018
- Descendant · 2 generations on · 26 of its ownK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 25 of its ownK221002 IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022
Show all 17 generations
- Root · 17 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 16 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 15 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 14 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 13 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 12 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 11 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 10 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 9 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 8 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 7 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 6 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 5 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 4 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 3 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 2 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 1 generation backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- This deviceK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · cites it directly88descendants
- K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd. · 2019 · cites it directly66descendants
- K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd. · 2018 · cites it directly36descendants
- K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022 · 2 generations on26descendants
- K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −16 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −15 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −14 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −13 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −12 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −11 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −10 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −9 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −8 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −7 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −6 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −5 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −4 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −3 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −2 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −1 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| 0 (this device) | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| +1 | 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 | — |
| +1 | K173813 | IPL Hair Removal Device Joy Version | Shen Zhen Cosbeauty Co., Ltd. | 2018 | — |
| +2 | K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | 2022 | — |
| +2 | K221002 | IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C | Shenzhen Ulike Smart Electronics Co., Ltd. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 27 | 0 |
| 2024 | 18 | 0 |
| 2025 | 18 | 0 |
| 2026 | 8 | 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? (1)
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…t code OHT Review panel: General & Plastic Surgery (3) Predicate device: iPulse SmoothSkin Gold Hair Removal System, cleared Apr. 14, 2016 (K160968) (4) Description of device: The PerfectSmooth is a personal, light-based, hair reduction device intended to be sold over-t… | 2016 |
What descends from it? (115)
See all 11510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181568 | IPL Salon Hair Reduction System | 2018 | 88 |
| K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 | 2019 | 66 |
| K173813 | IPL Hair Removal Device Joy Version | 2018 | 36 |
| K180016 | Home Use IPL Beauty Device | 2018 | 25 |
| K190820 | Aimanfun Lumea Comfort | 2019 | 22 |
| K183217 | IPL Hair Removal Device | 2019 | 3 |
| K203510 | IPL Hair removal | 2021 | 1 |
| K180383 | Light based hair removal device | 2018 | 1 |
| K232274 | IPL hair removal device | 2023 | 0 |
| K172883 | Home Use Hair Removal Device/T1, T2, T3 | 2018 | 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 22 years and passes through 11 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 51 ancestors has a recall of any class.
- Of its descendants, K181568 (Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt, 2018) has gone furthest, with 88 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. 2017, 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 PerfectSmooth 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 as stated in the FDA summary.
https://510kreport.com/device/K161428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161428: PerfectSmooth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161428
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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