The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.
Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 2)
“The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.”
Shenzhen Siken 3D Technology Development Co., Ltd.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“Multi-functional Facial Beauty Device (model: SKB-1909): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. - Red light is intended for the treatment of facial wrinkles. Multi-functional Facial Beauty Device (model: SKB-1703): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB2209): - Red light is intended for the treatment of facial wrinkles.”
Source discrepancy: this statement names “SBK-2109”, which doesn't appear in the device name in FDA's database. Both are shown exactly as FDA's records have them.