(378 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on microcurrent stimulation.
No
The device is described as being for "over-the-counter cosmetic use" and "stimulation of healthy facial skin," which places it outside the typical definition of a therapeutic device designed to treat a medical condition or disease.
No
The device is intended for stimulation of healthy facial skin for cosmetic use, not for diagnosing any medical condition.
No
The device description explicitly states it is a "hand-held, battery-powered device" and is used with "conductive treatment gel," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "stimulation of healthy facial skin" and "facial stimulation for over-the-counter cosmetic use." This clearly describes a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The device description mentions stimulating the face with microcurrents using a conductive gel. This aligns with a physical stimulation device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Facial Spa is intended for the stimulation of healthy facial skin.
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.
Product codes
NFO
Device Description
The Facial Spa is a hand-held, battery-powered device used with conductive treatment gel to stimulate the face with microcurrents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Page 1
| 510(k) Summary | |
|---|---|
| Submission Date: | Prepared September 4, 2012, updated September 17, 2013 |
| Submitter Information: | |
| Company Name: | Nu Skin Enterprises, Inc. |
| Company Address: | 75 West Center Street |
| Provo, UT 84601 | |
| Contact Person: | Tyler Whitehead |
| SEP 17 2013 | |
| Device Information: | |
| Trade Name: | Facial Spa |
| Common Name: | Facial Toning Device |
| Classification Name: | Transcutaneous electrical nerve stimulator 21 CFR 882.5890 |
| Regulation Class: | Class II |
| Product Code: | NFO |
| Predicate Devices: | NuFace® Plus (K103472) |
| Carol Cole Company | |
| Class II | |
| Device Description: | The Facial Spa is a hand-held, battery-powered device used with |
| conductive treatment gel to stimulate the face with microcurrents. | |
| Intended Use: | The Facial Spa is intended for the stimulation of healthy facial |
| skin. | |
| Indications for Use: | The Facial Spa is indicated for facial stimulation for over-the- |
| counter cosmetic use. | |
| Compliance Data: | The Facial Spa conforms to the applicable requirements of the |
| following standards: | |
| • IEC 60601-1 Issued: 1998/01/01 Ed: 2 Medical electrical | |
| equipment - Part 1: General requirements for basic safety | |
| and essential performance; Amendment 1-1991, | |
| Amendment 2-1995, Corrigendum - 1995 |
1
- . IEC 60601-1-2 Issued 2012/06/01 Ed: 3 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-10 Issued:1987/01/01 Ed:1 Medical Electrical . Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators
- IEC 60601-1-4 Issued: 2000/04/01 Ed:1.1 Medical . Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems Consolidated with Amd. 1:1999
- ISO ISO10993-10 / Ed.3, Biological evaluation of medical . devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-12 Biological evaluation of medical devices -Part 12: Sample Preparation and Reference Material
Comparison to Predicate Device:
The Facial Spa is identical to its predicate device in intended use and indications for use. It uses the same technological principle as the predicate device to accomplish its intended use, namely transcutaneous electrical stimulation. Both are hand-held, batterypowered devices. The present device raises no new questions of safety or effectiveness. A technical comparison of the two devices has been completed and supports a substantial equivalence determination.
Table: Comparison of Nu Skin Facial Spa and Carol Cole NuFace® Plus
| Features | Nu Skin Facial Spa (Subject Device) | Carol Cole NuFace® Plus (Predicate Device) |
|---|---|---|
| Similarities | ||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 |
| Regulation Name | Transcutaneous Electrical | |
| Nerve Stimulator | Transcutaneous Electrical | |
| Nerve Stimulator | ||
| Regulatory Class | Class II | Class II |
| Product Code | NFO | NFO |
| Intended Use | Stimulate the face | Stimulate the face |
2
Traditional 510(k) Premarket Notification Nu Skin Facial Spa
| Indications for Use | Over-the-Counter Cosmetic
Use | Over-the-Counter Cosmetic
Use |
|------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|
| Power Source | Battery operated | Battery operated |
| Average DC current through
electrodes when device is on
but no pulse being applied | 0 | 0 |
| Number of output channels | 1 | 1 |
| Microprocessor controlled | Yes (PLC) | Yes |
| Automatic no-load trip | Yes | Yes |
| Automatic shut off | Yes | Yes |
| User over-ride control | Yes | Yes |
| Indicator Display | | |
| On/off | Yes | Yes |
| Low-battery | Yes | Yes |
| On Time (seconds) | Constant | Constant |
| Off Time (seconds) | None | None |
| Compliance with Voluntary
Standards | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| Compliance with
21 C.F.R. § 898 | Yes | Yes |
| Differences | | |
| Differences . " | | ﻟ | ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ | ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | ﺎ
નું | : |
|-----------------|------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----|
| :
� | 19 17
, | ﻳ
r | 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
y
si | | .7 |
| Modes | One to Five | One |
|---|---|---|
| Maximum Output Voltage | @ 500 Ω | @ 500 Ω |
| Mode 1: 188 mV (214 mV) | 137 mV | |
| Mode 2: 189 mV (225 mV) | ||
| Mode 3: 185 mV (220 mV) | ||
| Mode 4: 184 mV (212 mV) | ||
| Mode 5: 184 mV (213 mV) | ||
| @ 2k Ω | @ 2k Ω | |
| Mode 1: 722 mV (1527 mV) | 769 mV | |
| Mode 2: 746 mV (812 mV) | ||
| Mode 3: 735 mV (815 mV) | ||
| Mode 4: 740 mV (802 mV) | ||
| Mode 5: 741 mV (801 mV) | ||
| @ 10 k Ω | @ 10 k Ω | |
| Mode 1: 2.626 V (2.978 V) | 3.82 V | |
| Mode 2: 3.787 V (4.011 V) | ||
| Mode 3: 3.747 V (4.014 V) | ||
| Mode 4: 3.503 V (3.980 V) | ||
| Mode 5: 3.729 V (3.980 V) |
Page 3
3
Traditional 510(k) Premarket Notification Nu Skin Facial Spa
Page 4
| Maximum Output Current | @ 500 Ω
Mode 1: 376 uA (427 uA)
Mode 2: 379 uA (449 uA)
Mode 3: 371 uA (440 uA)
Mode 4: 368 uA (424 uA)
Mode 5: 369 uA (427 uA)
@ 2 kΩ
Mode 1: 361 uA (763 uA)
Mode 2: 373 uA (406 uA)
Mode 3: 367 uA (407 uA)
Mode 4: 370 uA (401 uA)
Mode 5: 370 uA (400 uA)
@ 10 kΩ
Mode 1: 362 uA (398 uA)
Mode 2: 379 uA (401 uA)
Mode 3: 375 uA (401 uA)
Mode 4: 350 uA (398 uA)
Mode 5: 373 uA (398 uA) | @ 500 Ω
274 uA
@ 2 kΩ
387 uA
@ 10 kΩ
383 uA |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Waveform | Direct Current | Pulsed Monophasic |
| Weight | 120 g (approx. 4 oz) | 9 oz |
| Dimensions | Facial Spa with Large
Conductor: 143 x 31.2 x 67.5 mm (5.6" x 1.2" x 2.7")
Facial Spa with Small
Conductor: 136 x 31.2 x 67.5 mm (5.4" x 1.2" x 2.7") | 3" x 5.25" x 1.25" |
| Housing material and
construction | ABS, Chrome plated
ABS, rubber (elastomer) | Thermo Plastic |
Conclusion:
.
The Facial Spa is substantially equivalent to the predicate device, as the devices share a common intended use, and technological differences between the Facial Spa and the predicate do not raise new questions of safety or effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
September 17, 2013
NuSkin Enterprises, Inc. C/O Paul D. Rubin Ropes & Gray LLP One Metro Center 700 12th Street, Suite 900 Washington, DC 20005
Re: K122711
Trade/Device Name: NuSkin Facial Spa Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator Regulatory Class: Class II Product Code: NFO Dated: September 4, 2013 Received: September 4, 2013
Dear Mr. Rubin,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 -- Mr. Paul Rubin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name:_ NuSkin Facial Spa
Indications For Use:
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M.J nd -S
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