Electrical stimulation for aesthetic use (microcurrent and EMS)
Records FDA files under its code for transcutaneous electrical stimulators for aesthetic purposes, such as facial stimulation. FDA's code name doesn't say over-the-counter, so read each record.
82 records from 2001 to 2026, filed by 61 companies. 8 of the device names as filed include the word "microcurrent" and 1 mention EMS or electrical stimulation. We quote the indications for use for 38 of them from FDA's PDFs.
21 CFR 882.5890: “Transcutaneous electrical nerve stimulator for pain relief.” The regulation is titled for pain relief; FDA's product code NFO is the subset used for aesthetic purposes.
Each record is one FDA decision about the device named in it, for the use in its indications statement. The company that filed may be the brand on the box or the manufacturer that makes it for the brand.
Records are grouped by FDA product code; a record's own indications can be narrower, broader or different from the group name, so read each one. We quote an indications statement only when it comes from a text page of FDA's PDF (not a scan) and every word checks out; otherwise the entry says why and links the PDF, which is the authority.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
“The Aura Glide is an over-the-counter handheld device for aesthetic purposes. (1) The microcurrent mode is indicated for facial stimulation. (2) The LED mode is intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate inflammatory acne (blue light).”
“Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.”
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 4.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
“The BTL-785BNF-E device has the following indications for use: The device is indicated for aesthetic use including facial and neck or body skin stimulation.”
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
“The C.C.Life 21 device with C-Life handle (RF) is indicated for the temporary relief of minor muscle aches and pain temporary relief of muscle spasm, and temporary improvement of local blood circulation. The C.C.Life 21 device with C-Life Micro handle (TENS) is intended for facial stimulation and is indicated for cosmetic use.”
“The BTL-785BNF Handpiece device has the following indications for use: The device is indicated for aesthetic use including facial and neck stimulation or body skin stimulation.”
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.
“2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes. (1) The EMS mode is indicated for facial stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.”
“For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use. For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles, For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.”
“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.”
“The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.”
Source discrepancy: this statement names “MT-200”, which doesn't appear in the device name in FDA's database. Both are shown exactly as FDA's records have them.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 9.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 8.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 5.