Light Based Over-the-counter Hair Removal
General, Plastic Surgery · 21 CFR 878.4810
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Recent MDR events
32 adverse event reports on file
- Philips Lumea IPLJul 29, 2026MalfunctionPhilips Consumer Lifestyle B.v.3010359222-2026-100002
- LIGHT BASED OVER-THE-COUNTER HAIR REMOVALMay 11, 2026InjuryUnknownMW5187951
- INNZA IPL HAIR REMOVAL DEVICE, MODEL JD-TM016May 7, 2026InjuryFoshan Jindi Electric Appliance Co., Ltd.MW5187850
- ULIKE XApr 30, 2026MalfunctionShenzhen Ulike Smart Electronics Co., Ltd.3023339103-2026-00001
- OREETH IPL HAIR REMOVAL DEVICEApr 29, 2026InjuryDongguan Lide Electric Appliance Co., Ltd.3029992391-2026-00001
- OREETH IPL HAIR REMOVAL DEVICEMar 17, 2026InjuryDongguan Lide Electric Appliance Co., Ltd.MW5185280
- HAND-HELD HAIR REMOVAL DEVICEMar 9, 2026InjuryShenzhen Chuangtong Yigou Technology Co., Ltd.MW5184906
- ULIKE XMar 9, 2026MalfunctionShenzhen Ulike Smart Electronics Co.,ltdMW5184925
- IPL HAIR REMOVAL DEVICE CT05Feb 19, 2026InjuryShenzhen Chuangtong Yigou Technology Co., Ltd.MW5184093
- INNZA IPL HAIR REMOVALOct 9, 2025InjuryFoshan Jindi Electric Appliance Co.,ltdMW5177145
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
219 firms currently registered for this product code
Cyden Medical Technology (zhejiang) Co., Ltd
Jiashan Zhejiang, CN
Shenzhen Ulike Smart Electronics Co.,ltd
Shenzhen Guangdong, CN
Dc Altfeld - Procter & Gamble
Marktheidenfeld Hesse, DE
Guangzhou Telefield Limited
Guangzhou Guangdong, CN
Shenzhen Yang Wo Electronic Co., Ltd
Shenzhen Guangdong, CN
Ulike Company Limited
Ho Chi Minh, VN
Dreame Trading (tianjin) Co., Ltd.
Tianjin, CN
Ulike International Industrial Pte. Ltd.
Singapore North West, SG
Shenzhen Borria Technology Co.,ltd
Shenzhen Guangdong, CN
Cyden Ltd
Swansea, GB
Mustech Electronics Co., Limited
Shenzhen Guangdong, CN
Dongguan Boyuan Intelligent Technology Co., Ltd
DONGGUAN CITY Guangdong, CN
Philips Consumer Lifestyle B.v.
Drachten Fryslan, NL
Beijing Beautemax Technology Limited
Beijing, CN
Dongguan Define Beauty Electronic Technology Co.,ltd
Dongguan Guangdong, CN
Shenzhen Zowee Smart Manufacturing Co., Ltd.
Shenzhen Guangdong, CN
Shenzhen Semlamp Intelligent Technology Co., Ltd
Shenzhen Guangdong, CN
Silk'n Beauty Ltd.
Rotterdam Zuid-Holland, NL
Joicom Corporation
Eastvale, CA, US
510(k) clearances
162 clearances for this product code
- Shenzhen Ulike Smart Electronics Co., Ltd.May 21, 2026
K261325 · Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
- Shenzhen Xiazhifeng Electronic Co., Ltd.May 20, 2026
K260594 · IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
- Shenzhen Ulike Smart Electronics Co., Ltd.May 5, 2026
K260742 · Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
- Shenzhen Semlamp Intelligent Technology Co., Ltd.Apr 21, 2026
K260518 · IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
- Shenzhen Chuangtong Yigou Technology Co., Ltd.Mar 11, 2026
K254047 · Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
- Shenzhen Mlay Intelligent Technology Co., Ltd.Feb 23, 2026
K253666 · IPL Hair Removal Device (Models: T31A, T32A)
- Shenzhen Fansizhe Science and Technology Co., Ltd.Dec 29, 2025
K253881 · Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
- Philips Consumer Lifestyle B.V.Dec 23, 2025
K253754 · Philips Lumea IPL