510(k) K252318

Insufflator (OPTO-IFL1000) by Guangdong Optomedic Technologies, Inc. — Product Code HIF

K252318 is an FDA 510(k) premarket notification submitted by Guangdong Optomedic Technologies, Inc. for the device "Insufflator (OPTO-IFL1000)". The FDA issued a decision of Substantially Equivalent on April 16, 2026. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Guangdong Optomedic Technologies, Inc. has at least 8 other 510(k) clearances on record.