510(k) Report

510(k) · Cleared

Cleared

IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32

K230021510(k) TraditionalCleared Mar 31, 202386-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shenzhen Yangyi Technology ., Ltd. · OHT Light Based Over-The-Counter Hair Removal

Cleared on Mar 31, 2023 as substantially equivalent to K192432 (Shenzhen Bosidin Technology Co., Ltd., 2019) after an 86-day review. Its family tree reaches back 20 generations to 1995. 6 later devices descend from it.

Decided
Mar 31, 2023
Review
86 days
Class
Class II
Product code
OHT
Recalls
None
Predicates
1

Its longest line of descent runs back 20 generations to K950019 (1995). 58 ancestors in all, the oldest K892514 (1990). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2013: 3 other ancestors2012: 3 other ancestors2011: 1 other ancestor2008: 1 other ancestor2005: 1 other ancestor2002: 2 other ancestors2000: 4 other ancestors2003: 2 other ancestors2001: 4 other ancestors1999: 2 other ancestors1998: 4 other ancestors1997: 4 other ancestors1990: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor1993: 1 other ancestor2023: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 2 descendants clearedReference device: K220669 · IPL HAIR REMOVAL HANDSET, Model: IPL-666 · Shenzhen Junbobeauty Technology Co., Ltd. · 2022K950019 · Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 · Thermolase Corp. · 1995K963947 · Epilaser Normal Mode Ruby Laser · Spectrum Medical Technologies, Inc. · 1997K973324 · Starlight Pulsed Diode Array Laser System · Star Medical Technologies, Inc. · 1997K982940 · Lightsheer Pulsed Diode Array Laser System · Star Medical Technologies, Inc. · 1999K011747 · Palomar LC 100 Diode Laser · Palomar Medical Technologies, Inc. · 2001K032846 · Spectra Pulsed Diode Laser, Model DR-1 · Spectragenics, Inc. · 2003K052848 · Spectra Hair Removal Laser · Spectragenics, Inc. · 2005K060839 · Abc Hair Removal System · Palomar Medical Technologies, Inc. · 2006K072906 · SILK'N · Home Skinovations, Ltd. · 2008K082298 · Flash N' GO · Home Skinovations, Ltd. · 2008K090820 · Tria Hair Removal Laser System · Spectragenics, Inc. · 2009K103184 · Silk'n Flash N GO · Home Skinovations, Ltd. · 2010×2: 2 generations cleared close together, K121598 (2012), K123845 (2013) K131649 · ME · Syneron Beauty, Ltd. · 2013K143003 · iPulse Smooth Skin Gold Hair Removal System · Ipulse Limited · 2015K160968 · iPulse SmoothSkin Gold Hair Removal Device · Cyden Limited · 2016K161428 · PerfectSmooth · Shen Zhen Cosbeauty Co., Ltd. · 2017K181568 · IPL Salon Hair Reduction System · Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018K192432 · IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 · Shenzhen Bosidin Technology Co., Ltd. · 20191990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 5 other ancestors6 generations back: 4 other ancestors7 generations back: 10 other ancestors8 generations back: 10 other ancestors9 generations back: 4 other ancestors10 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants K192432 · IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 · Shenzhen Bosidin Technology Co., Ltd. · 2019K181568 · IPL Salon Hair Reduction System · Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018K161428 · PerfectSmooth · Shen Zhen Cosbeauty Co., Ltd. · 2017K160968 · iPulse SmoothSkin Gold Hair Removal Device · Cyden Limited · 2016K143003 · iPulse Smooth Skin Gold Hair Removal System · Ipulse Limited · 2015K131649 · ME · Syneron Beauty, Ltd. · 2013K123845 · ME · Syneron Beauty, Ltd. · 2013K121598 · ME HAIR2GO · Syneron Medical, Ltd. · 2012K103184 · Silk'n Flash N GO · Home Skinovations, Ltd. · 2010K090820 · Tria Hair Removal Laser System · Spectragenics, Inc. · 2009K082298 · Flash N' GO · Home Skinovations, Ltd. · 2008K072906 · SILK'N · Home Skinovations, Ltd. · 2008K060839 · Abc Hair Removal System · Palomar Medical Technologies, Inc. · 2006K052848 · Spectra Hair Removal Laser · Spectragenics, Inc. · 2005K032846 · Spectra Pulsed Diode Laser, Model DR-1 · Spectragenics, Inc. · 2003K011747 · Palomar LC 100 Diode Laser · Palomar Medical Technologies, Inc. · 2001K982940 · Lightsheer Pulsed Diode Array Laser System · Star Medical Technologies, Inc. · 1999K973324 · Starlight Pulsed Diode Array Laser System · Star Medical Technologies, Inc. · 1997K963947 · Epilaser Normal Mode Ruby Laser · Spectrum Medical Technologies, Inc. · 1997K950019 · Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 · Thermolase Corp. · 1995−20−15−10−50
  1. Root · 20 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 16 generations between
  3. 3 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
  4. 2 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
  5. 1 generation backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
  6. This deviceK230021 IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd. · 2023
  7. Descendant · cites it directly · 4 of its ownK232939 IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd. · 2023
  8. Descendant · 2 generations on · 3 of its ownK242710 Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2024
  9. Descendant · 3 generations on · 0 of its ownK261705 Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026
  10. Descendant · 3 generations on · 0 of its ownK260518 IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1…Shenzhen Semlamp Intelligent Technology Co., Ltd. · 2026
  11. Descendant · 3 generations on · 0 of its ownK251398 IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd. · 2025
Show all 20 generations
  1. Root · 20 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 19 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
  3. 18 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
  4. 17 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
  5. 16 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
  6. 15 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
  7. 14 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
  8. 13 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
  9. 12 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
  10. 11 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
  11. 10 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
  12. 9 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
  13. 8 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
  14. 7 generations backK123845 MESyneron Beauty, Ltd. · 2013
  15. 6 generations backK131649 MESyneron Beauty, Ltd. · 2013
  16. 5 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
  17. 4 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
  18. 3 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
  19. 2 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
  20. 1 generation backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
  21. This deviceK230021 IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd. · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2023: 22024: 12025: 12026: 2
2023high 2 (2023) · low 1 (2024)2026

Most influential descendants

Showing 5 of 6 · See all
  • K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd. · 2023 · cites it directly4descendants
  • K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2024 · 2 generations on3descendants
  • K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026 · 3 generations on0descendants
  • K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2…Shenzhen Semlamp Intelligent Technology Co., Ltd. · 2026 · 3 generations on0descendants
  • K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp.1995—
−19K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc.1997—
−18K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1997—
−17K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1999—
−16K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001—
−15K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003—
−14K052848Spectra Hair Removal LaserSpectragenics, Inc.2005—
−13K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006—
−12K072906SILK'NHome Skinovations, Ltd.2008—
−11K082298Flash N' GOHome Skinovations, Ltd.2008—
−10K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009—
−9K103184Silk'n Flash N GOHome Skinovations, Ltd.2010—
−8K121598ME HAIR2GOSyneron Medical, Ltd.2012—
−7K123845MESyneron Beauty, Ltd.2013—
−6K131649MESyneron Beauty, Ltd.2013—
−5K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015—
−4K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016—
−3K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017—
−2K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt2018—
−1K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129…Shenzhen Bosidin Technology Co., Ltd.2019—
0 (this device)K230021IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd.2023—
+1K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.2023—
+2K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.2024—
+3K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.2026—
+3K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371…Shenzhen Semlamp Intelligent Technology Co., Ltd.2026—
+3K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199310
199620
199740
199840
199920
200040
200140
200220
200320
200510
200810
201110
201230
201330
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
202410
202510
202620
FIG. 1 — Lineage of K230021, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130
Summary page 4
…Hair Removal Device Device Name and Model Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 510(k) Number K192432 Product Code OHT Regulation Number 21 CFR 878.4810 Regulation Class…
Shenzhen Bosidin Technology Co., Ltd.2019—
†K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.2022—

Also cleared against K192432: 12 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234
K233237xeo+ FamilyCutera, Inc.20230

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 28 years and passes through 14 companies; a new generation was cleared every 1.2 years on median.
  • 1 of the 58 ancestors has a recall of any class.
  • Of its descendants, K232939 (Shenzhen Borria Technology Co., Ltd., 2023) has gone furthest, with 4 descendants of its own.
  • 12 other devices also cite its predicate K192432.

How does its category compare?

All OHT devices

OHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · OHT

25in 2025

2010: 12012: 12013: 22014: 42015: 22016: 32017: 62018: 82019: 72020: 12021: 122022: 252023: 322024: 262025: 252026 (partial year): 11
2007high 32 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OHT

87in 2025

2014: 166 days median2016: 81 days median2017: 87 days median2018: 89 days median2019: 64 days median2021: 89 days median2022: 70 days median2023: 83 days median2024: 62 days median2025: 87 days median2026 (partial year): 84 days median
2007high 166 (2014) · low 62 (2024)2026

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

2015: 12016: 22019: 22020: 32021: 12022: 22023: 62025: 6
2007high 6 (2023) · low 0 (2007)2025

MAUDE reports naming product code OHT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20121—00
20132—00
2014416600
20152—01
201638102
201768700
201888900
201976402
20201—03
2021128901
2022257002
2023328306
2024266200
2025258706
202611840—

What is it indicated for?

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K230021: IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230021

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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