Energy Based Device for Treatment of Tattoos
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Beijing and Hebei: 3 hold an FDA registration.
- Beijing Perfectlaser Technology Co., Ltd. Beijing
- Beijing Spiritlaser Science & Technology Co., Ltd. Beijing, contract manufacturer
- Sanhe Jumei Technology Co., Ltd. Hebei
What Is This Device?
To reduce formation of bubbles during laser treatment of tattoos
What Is FDA Product Code QHF?
Energy Based Device For Treatment Of Tattoos is FDA product code QHF, 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.
Name
Record