ClearanceBrief
510(k) K251545 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Intense Pulsed Light Therapy Device (MMABM-1)

ApplicantMicowey Medical Equipment (Guangxi) Co., Ltd., Wuzhou, CN
DecisionSubstantially Equivalent, Sep 4, 2025
ReceivedMay 20, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251545

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.