ClearanceBrief
510(k) K230739 ยท OHT Light Based Over-The-Counter Hair Removal

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

ApplicantShenzhen Ionka Medical Technology Co., Ltd., Shenzhen, CN
DecisionSubstantially Equivalent, May 26, 2023
ReceivedMar 17, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230739

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.