FDA.reportPublic FDA data

510(k) K242197

Device
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
Applicant
Shenzhen Huaruibo Electric Appliances Co., Ltd.
510(k) number
K242197
Product code
OHT
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-17
Date received
2024-07-26
Regulation
878.4810
Classification name
Light Based Over-The-Counter Hair Removal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xinhua Luo
Address
3rd Floor, Bldg. A, Chajiaokan Industrial Zone, Sanhe Village, Huarong Community, Dalang St., Longhua District Shenzhen CN 518103 518103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OHT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.2026-08-10
K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.2026-05-21
K260594IPL 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 Xiazhifeng Electronic Co., Ltd.2026-05-20
K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.2026-05-05
K260518IPL 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 Semlamp Intelligent Technology Co., Ltd.2026-04-21
K254047Hair 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 Chuangtong Yigou Technology Co., Ltd.2026-03-11
K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.2026-02-23
K253881Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)Shenzhen Fansizhe Science and Technology Co., Ltd.2025-12-29
K253754Philips Lumea IPLPhilips Consumer Lifestyle B.V.2025-12-23
K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)Dongguan Lide Electric Appliance Co., Ltd.2025-11-25
K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.2025-11-19
K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co. , Ltd.2025-11-14
K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)Shenzhen Qiaochengli Technology Co., Ltd.2025-10-14
K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd.2025-10-10
K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.2025-10-02