Unit, Electrolysis, Ac-Powered, Ophthalmic
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Beijing.
- Beijing Hongdee Corporation Beijing
How Is HRO Classified?
Unit, Electrolysis, Ac-Powered, Ophthalmic is FDA product code HRO, Class 2, 21 CFR 886.4250.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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