510(k) K253112

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) by Hlb Lifescience Co., Ltd. — Product Code FMF

K253112 is an FDA 510(k) premarket notification submitted by Hlb Lifescience Co., Ltd. for the device "Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)". The FDA issued a decision of Substantially Equivalent on May 21, 2026. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Hlb Lifescience Co., Ltd. has at least 1 other 510(k) clearance on record.