Laser Assisted Lipolysis
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Beijing and Hebei.
What Is This Device?
Intended to be used for laser assisted lipolysis
How Is ORK Classified?
Laser Assisted Lipolysis is FDA product code ORK, Class 2, 21 CFR 878.4810.
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.
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