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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.

What FDA's code NFO covers

FDA device name
“Stimulator, Transcutaneous Electrical, Aesthetic Purposes”
Regulation
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.
Device class
Class II

Quoted from FDA's Product Classification database entry for NFO, checked October 12, 2026.

All 82 records, newest first

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.

20262025202420232022202120202019201820172016201520142013201220112008200720052001

2026 (7)

510(k) cleared

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

510(k) number
K261370
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

PureLift Pro Max

510(k) number
K262861
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

510(k) cleared

SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)

510(k) number
K260387
Applicant
Hironic Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. FDA doesn't host a document for this record at the usual address.

510(k) cleared

FACEGYM Pro Device (HD-109)

510(k) number
K253932
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The FACEGYM Pro Device (Model: HD-109) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

510(k) cleared

VITA Multi-Function Head Brush (TB-2343F, TB-2442F)

510(k) number
K260179
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

Ulike Clear Zero (YC10 BU)

510(k) number
K260895
Applicant
Guangxi Ulike Medical Technology Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

DeepSkin (DEP100)

510(k) number
K252621
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Microcurrent Device (Model: DEP100) is intended for facial stimulation for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

2025 (16)

510(k) cleared

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

510(k) number
K252146
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

Aura Glide (FC40)

510(k) number
K252187
Applicant
Aura Medical, LLC
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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).”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Medi Lift Essential Eye Mask

510(k) number
K250618
Applicant
Ya-Man, Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

JOVS Electric Stimulation Beauty Device (JE2)

510(k) number
K250227
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)

510(k) number
K251034
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. FDA doesn't host a document for this record at the usual address.

510(k) cleared

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

510(k) number
K252553
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Sunny Plus (Sunny)

510(k) number
K251649
Applicant
ShenB Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

NeurotriS (SX2500); NeurotriS (SX3800)

510(k) number
K251909
Applicant
A-1 Engineering
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

MF SC GEN2 Facial Toning System

510(k) number
K252218
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received
(third-party review)

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

Microcurrent Facial Device (CEC101, EE0101, EEI101)

510(k) number
K244004
Applicant
Shenzhen Dachi Communication Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1

510(k) number
K250361
Applicant
Geske Beauty Tech GmbH
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

Préime DermaFacial (MicroT)

510(k) number
K243072
Applicant
EMA Aesthetics , Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

PureLift GLOW

510(k) number
K243587
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

Myolight Microcurrent Handpiece

510(k) number
K243063
Applicant
Raja Trading Company, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)

510(k) number
K243393
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

Medi Lift Mask

510(k) number
K244048
Applicant
Ya-Man, Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

2024 (5)

510(k) cleared

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

510(k) number
K243430
Applicant
Shenzhen Aozemei Technology Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

BTL-785BNF-E

510(k) number
K242532
Applicant
BTL Industries, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 7), with line breaks removed.

510(k) cleared

BEAR 2 Body

510(k) number
K232242
Applicant
Foreo, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Facial Toning device (UIC-189); Facial Toning device (UIC-589)

510(k) number
K233667
Applicant
Body Trim Industrial Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

2023 (8)

510(k) cleared

MF SC Facial Toning System

510(k) number
K233525
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received
(third-party review)

Indications for use, as filed

“The MF SC Facial Toning System is intended to stimulate the face. The device is indicated for over the counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Nu Skin RenuSpa iO

510(k) number
K232001
Applicant
Nse Products, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Beagank 4T Plus

510(k) number
K233010
Applicant
Belega, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

C.C. Life 21

510(k) number
K230459
Applicant
21 Equipment S.R.L.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

BTL-785BNF Handpiece

510(k) number
K232172
Applicant
BTL Industries, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Medi Lift PLUS

510(k) number
K220198
Applicant
Ya-Man, Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

PureLift Pro Edition

510(k) number
K230506
Applicant
Xtreem Pulse
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Myolift QT

510(k) number
K213078
Applicant
Johari Digital Healthcare Limited
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

““Myolift QT” is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

2022 (2)

510(k) cleared

PureLift Pro Plus

510(k) number
K221443
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

510(k) cleared

Luminice

510(k) number
K214100
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

2021 (7)

510(k) cleared

Microcurrent device (Model: HBR2-1)

510(k) number
K211055
Applicant
Shenzhen DJ Medical Equipment Co., Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

TheraFace Microcurrent

510(k) number
K212238
Applicant
Theragun, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

ZIIP+ Device

510(k) number
K212342
Applicant
Ziip, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The ZIIP+ Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device

510(k) number
K191951
Applicant
Avazzia, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

Trinity ELE Plus and Trinity ELE Plus Pro

510(k) number
K201906
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

NuFACE Mini Plus

510(k) number
K201680
Applicant
Carole Cole Company
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

NuFace Trinity Plus Device

510(k) number
K201782
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The NūFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

2020 (2)

510(k) cleared

Tua Face Fitness / Tua Trend Face

510(k) number
K192077
Applicant
Vupiesse S.R.L
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Tua Face Fitness / Tua Trend Face is a device intended for facial stimulation and is indicated for Over-the-Counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

BEAR and BEAR mini

510(k) number
K200803
Applicant
Foreo, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

2019 (3)

510(k) cleared

NuFACE Mini Device

510(k) number
K191672
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

PureLift

510(k) number
K190269
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Ultra OTC Facial Toning System

510(k) number
K183189
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.

2018 (5)

510(k) cleared

NuFACE FIX Skin Toning Device

510(k) number
K182424
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

NuFACE Trinity

510(k) number
K181008
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Ultra Facial Toning System

510(k) number
K181062
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

TAMA BEMS device

510(k) number
K173093
Applicant
Tama Research Corporation
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

2 Face / Face Evolution

510(k) number
K171821
Applicant
Heat IN A Click
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

2017 (7)

510(k) cleared

Pobling MIITY 2

510(k) number
K163550
Applicant
Habalan Med & Beauty Co.,Ltd
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Pobling MIITY 2 is intended for facial stimulation and is indicated for over-the counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Smart Photon Micro-current Device, Model: EP-300

510(k) number
K162652
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

510(k) cleared

BeneLife Premium Facial Treatment Pack, Model: QZ0701A

510(k) number
K171647
Applicant
Infinitus (China) Company , Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

NuBODY Skin Toning Device

510(k) number
K171588
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Galvanic Spa, Model: SKB-1405

510(k) number
K163470
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

ZIIP Device

510(k) number
K161484
Applicant
Ziip,Llc
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The ZIIP Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Micro-current Wrinkle Reduction Facial service, model EP-400

510(k) number
K162106
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“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.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

2016 (2)

510(k) cleared

RejuvatoneMD

510(k) number
K152199
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Nutra Face Lift Model PE8050

510(k) number
K150826
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

2015 (2)

510(k) cleared

SonicLift

510(k) number
K150077
Applicant
Pretika Corporation
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“This device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Everyway Facial MENS

510(k) number
K142794
Applicant
Everyway Medical Instruments Co.,Ltd
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Everyway Facial MENS, model: MT-200 is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

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.

2014 (2)

510(k) cleared

BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE

510(k) number
K130065
Applicant
Biosonic Technologies, LLC
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

NUFACE MINI DEVICE

510(k) number
K133823
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

2013 (2)

510(k) cleared

TRINITY ELE

510(k) number
K131251
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

FACIAL SPA

510(k) number
K122711
Applicant
Nuskin
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

2012 (3)

510(k) cleared

AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM

510(k) number
K120511
Applicant
Leto Enterprise , Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

510(k) cleared

ULTRA BEAUTY

510(k) number
K112351
Applicant
Johari Digital Healthcare , Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

ELECTROPULSE-COSMETIC

510(k) number
K113724
Applicant
Pain Relief Technologies
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

2011 (3)

510(k) cleared

THE BUZZ FACIAL TONING SYSTEM

510(k) number
K102494
Applicant
Daka International , Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.

510(k) cleared

BMR FACE

510(k) number
K103031
Applicant
Bio-Medical Research, Ltd.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

NUFACE PLUS

510(k) number
K103472
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

2008 (3)

510(k) cleared

RUGALIFT, MODEL# V.2.1

510(k) number
K071573
Applicant
Fatrotek S.R.L.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

NUTRITONE FACIAL BEAUTY SYSTEM

510(k) number
K070250
Applicant
Isomers Laboratories, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE

510(k) number
K070217
Applicant
Neuro Resource Group, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

2007 (1)

510(k) cleared

NUFACE, MODEL NU-4003

510(k) number
K072260
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

2005 (1)

510(k) cleared

FACEMASTER FACIAL TONING SYSTEM

510(k) number
K040871
Applicant
Facemaster of Beverly Hills, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

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.

2001 (1)

510(k) cleared

REJUVENIQUE MODEL #RJV10

510(k) number
K011935
Applicant
Salton, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.