510(k) K243421

Lelo Hex Lubricated Natural Rubber Latex Condom by Lelo, Inc. — Product Code HIS

K243421 is an FDA 510(k) premarket notification submitted by Lelo, Inc. for the device "Lelo Hex Lubricated Natural Rubber Latex Condom". The FDA issued a decision of Substantially Equivalent on March 7, 2025. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Lelo, Inc. has at least 2 other 510(k) clearances on record.