510(k) K222537

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi by Shenzhen Ishine Technology Company Limited — Product Code OHT

K222537 is an FDA 510(k) premarket notification submitted by Shenzhen Ishine Technology Company Limited for the device "IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi". The FDA issued a decision of Substantially Equivalent on Oct 14, 2022. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810.