FDA.reportPublic FDA data

510(k) K253881

Device
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
Applicant
Shenzhen Fansizhe Science and Technology Co., Ltd.
510(k) number
K253881
Product code
OHT
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-29
Date received
2025-12-04
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
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Endang Cheng
Address
2nd, 3rd And 4th Floors, #11, Henggangxia Industrial Zone Xiangshan Community, Xinqiao St., Bao’An District Shenzhen CN 518125 518125

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
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
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
K252804Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,Shenzhen Ulike Smart Electronics Co., Ltd.2025-10-01
K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)Miley Technology (Hebei) Co., Ltd.2025-09-15