510(k) Report

510(k) · Cleared

Cleared

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)

K241120510(k) TraditionalCleared Jun 24, 202462-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

Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal

Cleared on Jun 24, 2024 as substantially equivalent to K231613 (Zhuzhou Goldenhot Medical Technology Co., Ltd., 2023) and 1 other predicate after a 62-day review. Its family tree reaches back 24 generations to 1995. 1 later device descends from it.

Decided
Jun 24, 2024
Review
62 days
Class
Class II
Product code
OHT
Recalls
None
Predicates
2

Its longest line of descent runs back 24 generations to K950019 (1995). 65 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2022: 2 other ancestors2018: 1 other ancestor2014: 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 ancestor2025: 1 descendant clearedReference device: K213041 · IPL Hair Removal, Model: OBT-02 · Glan Electronics Co., Ltd. · 2021K950019 · 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. · 2019K210311 · Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. · Shenzhen Mismon Technology Co., Ltd. · 2021K220222 · IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4 · Shenzhen Yuwei Electronic Technology Co., Ltd. · 2022×2: 2 generations cleared close together, K223928 (2023), K231613 (2023) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor5 generations back: 1 other ancestor7 generations back: 1 other ancestor8 generations back: 3 other ancestors9 generations back: 5 other ancestors10 generations back: 4 other ancestors11 generations back: 10 other ancestors12 generations back: 10 other ancestors13 generations back: 4 other ancestors14 generations back: 1 other ancestor 1 generation forward: 1 descendant K231613 · Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. · Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2023K223928 · Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K · Shenzhen Fansizhe Science and Technology Co., Ltd. · 2023K220222 · IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4 · Shenzhen Yuwei Electronic Technology Co., Ltd. · 2022K210311 · Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. · Shenzhen Mismon Technology Co., Ltd. · 2021K192432 · 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 · 24 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 20 generations between
  3. 3 generations backK220222 IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd. · 2022
  4. 2 generations backK223928 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2023
  5. 1 generation backK231613 Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B…Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2023
  6. This deviceK241120 Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. · 2024
  7. Descendant · cites it directly · 0 of its ownK252234 IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13…Shenzhen Qiaochengli Technology Co., Ltd. · 2025
Show all 24 generations
  1. Root · 24 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 23 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
  3. 22 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
  4. 21 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
  5. 20 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
  6. 19 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
  7. 18 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
  8. 17 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
  9. 16 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
  10. 15 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
  11. 14 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
  12. 13 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
  13. 12 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
  14. 11 generations backK123845 MESyneron Beauty, Ltd. · 2013
  15. 10 generations backK131649 MESyneron Beauty, Ltd. · 2013
  16. 9 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
  17. 8 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
  18. 7 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
  19. 6 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
  20. 5 generations backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
  21. 4 generations backK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
  22. 3 generations backK220222 IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd. · 2022
  23. 2 generations backK223928 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2023
  24. 1 generation backK231613 Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B…Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2023
  25. This deviceK241120 Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−24K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp.1995—
−23K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc.1997—
−22K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1997—
−21K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1999—
−20K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001—
−19K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003—
−18K052848Spectra Hair Removal LaserSpectragenics, Inc.2005—
−17K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006—
−16K072906SILK'NHome Skinovations, Ltd.2008—
−15K082298Flash N' GOHome Skinovations, Ltd.2008—
−14K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009—
−13K103184Silk'n Flash N GOHome Skinovations, Ltd.2010—
−12K121598ME HAIR2GOSyneron Medical, Ltd.2012—
−11K123845MESyneron Beauty, Ltd.2013—
−10K131649MESyneron Beauty, Ltd.2013—
−9K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015—
−8K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016—
−7K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017—
−6K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt2018—
−5K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129…Shenzhen Bosidin Technology Co., Ltd.2019—
−4K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B…Shenzhen Mismon Technology Co., Ltd.2021—
−3K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.2022—
−2K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D…Shenzhen Fansizhe Science and Technology Co., Ltd.2023—
−1K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G…Zhuzhou Goldenhot Medical Technology Co., Ltd.2023—
0 (this device)K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.2024—
+1K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15…Shenzhen Qiaochengli 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
201810
202220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K241120, 1995–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…
Summary page 5
…del(s): DE01A-B, DE01A-G, Zhuzhou Goldenhot DE01B-B, DE01BG, DE01C-B, Medical Technology K231613 Jul. 31, 2023 DE01C-G, DE02A-B, DE02A-G, Co., Ltd. DE02B…
Zhuzhou Goldenhot Medical Technology Co., Ltd.2023—
*K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Summary page 5
…DE02C-G. Shenzhen Fansizhe Intense Pulsed Light (IPL) System, Science And K221569 Jun. 30, 2022 model T013C, T015C, T015K Technology Co., Ltd Reference device:…
Shenzhen Fansizhe Science and Technology Co., Ltd.2022—
†K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.2021—

Also cleared against K231613: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd.20250

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 29 years and passes through 18 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 65 ancestors has a recall of any class.
  • Of its descendants, K252234 (Shenzhen Qiaochengli Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K231613.

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. 2024, 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?

Intense pulsed light therapy apparatus 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. “K241120: Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241120

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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