510(k) K260795

Hand-held Dental X-ray System (HyperLight-M) by Changzhou Sifary Medical Technology Co., Ltd. — Product Code EHD

K260795 is an FDA 510(k) premarket notification submitted by Changzhou Sifary Medical Technology Co., Ltd. for the device "Hand-held Dental X-ray System (HyperLight-M)". The FDA issued a decision of Substantially Equivalent on September 14, 2026. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Changzhou Sifary Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.