510(k) K972093

REGENESIS MODEL 42 by Regenesis Biomedical, Inc. — Product Code ILX

K972093 is an FDA 510(k) premarket notification submitted by Regenesis Biomedical, Inc. for the device "REGENESIS MODEL 42". The FDA issued a decision of Substantially Equivalent on October 21, 1997. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Regenesis Biomedical, Inc. has at least 3 other 510(k) clearances on record.