Over-The-Counter Radiofrequency Coagulation Device for Wrinkle Reduction

Who Makes This Device Type in China?

3 of the 7 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Fujian and Beijing, and 1 other province.

Beijing Spiritlaser Science & Technology Co., Ltd. Beijing, contract manufacturer
Shenzhen Rainbow Technology Co., Ltd. Guangdong
Something High Electric (Xiamen) Company Inc. Fujian, contract manufacturer
Shen Zhen HanShine Technology Co., Ltd. Guangdong, contract manufacturer
Shenzhen Lescolton Medical Equipment Co., Ltd. Guangdong
VIS (Shanghai) Technology Co., Ltd. Shanghai
Xiamen Solex High-Tech Industries Co., Ltd. Fujian, contract manufacturer

What Is It?

An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

What Is FDA Product Code PAY?

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction is FDA product code PAY, Class 2, 21 CFR 878.4420.

What Does It Take to Sell It in the United States?

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.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Desire Model U

Tripollar Desire Packed Rose Gold USA

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Stop VX Gold Model U

The STOP U Model UXV treats mild to moderate facial wrinkles non-invasively in adults with Fitzpatrick skin types II to IV. The system consists of an applicator, power supply and…

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

MyLift

Catalogue number Model VXU-302, listed by Pollogen Ltd, Israel, under Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction. 7 manufacturers in China are registered for this product code.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Newa+, Kit, US, Pink

The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Aura

Catalogue number Model VXU-301, listed by Pollogen Ltd, Israel, under Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction. 7 manufacturers in China are registered for this product code.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Stop VX2 Model U

Catalogue number STOP VX2 MODEL U, listed by Pollogen Ltd, Israel, under Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction. 7 manufacturers in China are registered for this product code.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Geneo, GLO2FACIAL, Elite

The filed RF PRO handpiece kit, formerly the TriPollar RF Applicator kit, is used with the GENEO X ELITE platform. With this applicator, the system is intended for non-invasive treatment of…

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Stop VX Model U

STOP U Model UXV is a home use radiofrequency device for noninvasive treatment of mild to moderate facial wrinkles. It is intended for adult users with Fitzpatrick skin types II to IV and…

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

FAQ 101

FAQ™ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Silk’n

The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types…

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Silk’n

The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types…

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Sensilift

The Sensilift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Newa Kit

The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman who have Fitzpatrick skin types I-IV.

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Stop X

STOP X Model STOP U is a home-use radiofrequency device for noninvasive treatment of mild to moderate facial wrinkles. It is intended for adult users with Fitzpatrick skin types II to IV.…

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Newa Plus Kit

The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer