510(k) K090663

AMS SPECTRA CONCEALABLE PENILE PROSTHESIS by American Medical Systems, Inc. — Product Code FAE

K090663 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS SPECTRA CONCEALABLE PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 9, 2009. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.