ClearanceBrief
510(k) K231997 ยท ILY Lamp, Infrared, Therapeutic Heating

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

ApplicantCure Point Therapeutics, Inc., Cheyenne WY, US
DecisionSubstantially Equivalent, Oct 15, 2024
ReceivedJul 5, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231997

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.