Eyelid Thermal Pulsation System

What Is It?

Therapeutic application of heat and massage to the eyelids.

What Is FDA Product Code ORZ?

Eyelid Thermal Pulsation System is FDA product code ORZ, Class 2, 21 CFR 886.5200.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Device Design (1), No Marketing Application (1) and Labeling Change Control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.