Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

OHT · Predicate Candidate Screening

162 FDA 510(k) clearances under this product code; the 50 most recent screened below.

84 daysmedian FDA review time
172 days90th percentile
162clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI0Shenzhen Ulike Smart Electronics Co., Ltd.2026-05-21290
K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FLShenzhen Xiazhifeng Electronic Co., Ltd.2026-05-20860
K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI2Shenzhen Ulike Smart Electronics Co., Ltd.2026-05-05600
K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-BShenzhen Semlamp Intelligent Technology Co., Ltd.2026-04-21630
K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CShenzhen Chuangtong Yigou Technology Co., Ltd.2026-03-11840
K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.2026-02-23940
K253881Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, TShenzhen Fansizhe Science and Technology Co., Ltd.2025-12-29250
K253754Philips Lumea IPLPhilips Consumer Lifestyle B.V.2025-12-23280
K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18Dongguan Lide Electric Appliance Co., Ltd.2025-11-25570
K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.2025-11-19580
K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co. , Ltd.2025-11-14870
K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA1Shenzhen Qiaochengli Technology Co., Ltd.2025-10-14890
K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM0Foshan Jindi Electric Appliance Co., Ltd.2025-10-10870
K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.2025-10-021490
K252804Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI2Shenzhen Ulike Smart Electronics Co., Ltd.2025-10-01280
K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device Miley Technology (Hebei) Co., Ltd.2025-09-15840
K251176IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, TShenzhen Mlay Intelligent Technology Co., , Ltd.2025-08-141200
K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd.2025-08-01590
K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI0Shenzhen Ulike Smart Electronics Co., Ltd.2025-07-24270
K251173Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, TShenzhen Fansizhe Science and Technology Co., Ltd.2025-07-14890
K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI2Shenzhen Ulike Smart Electronics Co., Ltd.2025-07-111050
K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05Shenzhen Chuangtong Yigou Technology Co., Ltd.2025-06-30900
K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04,Bestway Plastic and Metal Products , Ltd.2025-06-152610
K250384IPL400El Global Trade, Ltd.2025-05-231010
K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 Shenzhen Ulike Smart Electronics Co., Ltd.2025-05-23560
K250253IPL Hair Removal Device (KCA511/KCA516/KCA522)Dongguan Boyuan Intelligent Technology Co.,Ltd2025-05-06980
K243017IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)Foshan Newface Electronic Technology Co., Ltd.2025-05-062210
K250194Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI0Shenzhen Ulike Smart Electronics Co., Ltd.2025-03-26620
K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, Mustech Electronics Co., Limited2025-03-19610
K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.2025-03-19570
K243453Philips Lumea IPLPhilips Consumer Lifestyle B.V.2025-02-10950
K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G,Zhuzhou Goldenhot Medical Technology Co., Ltd.2024-12-21820
K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 Shenzhen Ulike Smart Electronics Co., Ltd.2024-12-131570
K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro,Shenzhen Jianchao Intelligent Technology Co., Ltd.2024-12-06880
K243362SmoothSkin Pure Switch (SSC1)Cyden Limited2024-11-27290
K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18Shenzhen Greatro Electronic Technology Co., Ltd.2024-11-07690
K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIMShenzhen Ulike Smart Electronics Co., Ltd.2024-11-061170
K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd.2024-10-25280
K242197IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)Shenzhen Huaruibo Electric Appliances Co., Ltd.2024-10-17830
K241834IPL Hair Removal Device (BE932C, BE932D, BE932E)Shenzhen Yang WO Electronic Co., Ltd.2024-09-23900
K241205Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Shenzhen Ulike Smart Electronics Co., Ltd.2024-09-091320
K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd.2024-08-29620
K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.2024-07-101900
K241343IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T12Shenzhen Lescolton Electrical Appliance Co., Ltd.2024-07-09570
K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03,Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.2024-06-24620
K240649Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 Shenzhen Ulike Smart Electronics Co., Ltd.2024-06-211060
K240583IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.2024-06-181090
K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd.2024-05-31520
K241106Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10BShenzhen Mlay Intelligent Technology Co., , Ltd.2024-05-22300
K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.2024-04-241030

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda