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The Tracker / September 2026 / K260795

510(k) cleared

Hand-held Dental X-ray System (HyperLight-M)

Changzhou Sifary Medical Technology Co., Ltd. · Sep 14, 2026 · K260795

FDA cleared the Hand-held Dental X-ray System (HyperLight-M) from Changzhou Sifary Medical Technology Co., Ltd. on Sep 14, 2026 under K260795, a traditional 510(k). The device falls under product code EHD, Unit, X-Ray, Extraoral With Timer, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 11, 2026. The decision came 187 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Changzhou Sifary Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252224 (Apex Locator (FindPex)).

Questions & Answers

What did FDA clear under K260795?

K260795 is the FDA 510(k) for Hand-held Dental X-ray System (HyperLight-M), submitted by Changzhou Sifary Medical Technology Co., Ltd.. FDA's decision date was Sep 14, 2026, under product code EHD (Unit, X-Ray, Extraoral With Timer).

Who makes the Hand-held Dental X-ray System (HyperLight-M)?

Changzhou Sifary Medical Technology Co., Ltd., based in Changzhou, is the applicant of record for K260795.

How long did the K260795 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on Sep 14, 2026, 187 days later.

← All decisions in September 2026

Sources