HyperLight Portable X-ray Unit

FDA 510(k) K232068 · Changzhou Sifary Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK232068

Submission

Device name
HyperLight Portable X-ray Unit
Applicant
Changzhou Sifary Medical Technology Co., Ltd.
Changzhou, CN
Received
July 12, 2023
Decision date
September 1, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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Questions and answers

When was HyperLight Portable X-ray Unit cleared by the FDA?

HyperLight Portable X-ray Unit (K232068) received a 510(k) decision of Substantially Equivalent on September 1, 2023, 51 days after the submission was received.

What is the product code of K232068?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.