HyperLight Portable X-ray Unit | US FDA Approval

We are thrilled to announce that the HyperLight Portable X-ray Unit has received clearance from the U.S. Food and Drug Administration (FDA) as of September 1, 2023. This significant milestone underscores our commitment to providing cutting-edge, safe, and effective diagnostic tools for dental professionals.

FDA Clearance Details

The FDA's 510(k) premarket notification process has determined that the HyperLight Portable X-ray Unit is substantially equivalent to legally marketed predicate devices. This determination allows us to market the device in the United States, ensuring it meets stringent regulatory standards. The device is classified under:

• Regulation Number: 21 CFR 872.1800
• Regulation Name: Extraoral source x-ray system
• Regulatory Class: Class II
• Product Code: EHD

About the HyperLight Portable X-ray Unit

Designed by Changzhou Sifary Medical Technology Co., Ltd., the HyperLight Portable X-ray Unit is a handheld diagnostic device intended for use by trained dentists and dental technicians. It serves as an extraoral X-ray source for producing diagnostic images using intraoral receptors and is suitable for both adult and pediatric patients.

Key Features:

• Portability: Its handheld design ensures ease of use across various clinical settings, enhancing flexibility and patient comfort.
• Advanced Technology: Utilizes a constant potential (DC) X-ray generator, providing consistent and high-quality imaging.
• Safety: Incorporates internal and external shielding, allowing clinicians to remain in the operatory with patients during exposure.

Commitment to Excellence

At ProElite Dental, we are dedicated to equipping dental professionals with state-of-the-art tools that enhance diagnostic capabilities and patient care. The FDA clearance of the HyperLight Portable X-ray Unit reflects our ongoing efforts to deliver innovative solutions that meet the highest standards of safety and effectiveness.

We look forward to integrating this advanced imaging technology into dental practices nationwide, supporting clinicians in delivering exceptional care to their patients.

For more detailed information, please refer to the official FDA clearance document. Click Here