(311 days)
Not Found
No
The summary describes a device using electrical stimulation and light therapy, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of periorbital wrinkles" and "treatment of the mild to moderate inflammatory acne," which directly refers to treating medical conditions.
No
The device is intended for aesthetic purposes, specifically facial stimulation, treatment of periorbital wrinkles, and treatment of mild to moderate inflammatory acne, which are all therapeutic or cosmetic uses, not diagnostic.
No
The device description explicitly states it consists of a "Main Unit, conductive gel, charger and user manual," and is a "hand-held device." It also describes physical components like "treatment probes" and modes that involve emitting light and microcurrents, which are hardware functions. While it mentions IEC 62304 (Medical device software), this standard applies to software used within a medical device, not necessarily indicating the device itself is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "over-the counter aesthetic purposes," "facial stimulation," and "treatment of periorbital wrinkles and the mild to moderate inflammatory acne." These are all applications directly on the body for cosmetic or therapeutic effects, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device uses EMS (microcurrent) and Photon (red and blue light) modes, which are applied externally to the skin.
- Performance Studies: The performance studies listed are related to electrical safety, biocompatibility, usability, and specific standards for medical electrical equipment and light source equipment, not studies related to the performance of an in vitro diagnostic test.
IVD devices are used to test samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. This device operates directly on the skin for aesthetic and therapeutic purposes.
N/A
Intended Use / Indications for Use
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 intented for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Product codes
NFO, OHS, OLP
Device Description
2 Face / Face Evolution (Model: 2 Face / Face Evolution) is consists of a Main Unit, conductive gel, charger and user manual, it's a multifunctional comprehensive beauty instrument. It's combined with the most effective two kinds of techniques of internationally recognized skin care:
The EMS Mode is intended for facial stimulation for aesthetic purposes. It produces microcurrent discharged through the EMS Mode treatment probe. Microcurrent is an aesthetic modality providing electric current in millionths of an ampere. The EMS mode is indicated for aesthetic facial stimulation and requires the use of conductive gel. 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. It emits energy in the red spectrum for the treatment of periorbital wrinkles. The PHOTON Mode treatment probe is designed for contact with the face. The device continually pulses the light output, and provides 4 kinds of output intensity level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home
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)
2 Face / Face Evolution has been evaluated the safety and performance by lab bench testing as following:
- AAMI / ANSI / ISO 10993-5:2009(R) 2014, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility).
- ◆ ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
- IEC / EN 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
- IEC 60601-2-11 (First Edition):2010, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, monitoring and cosmetic/aesthetic use
- ◆ IEC 60601-1-6: 2010 (Third Edition), Medical electrical equipment - Part 1-6 General requirements for safety - Collateral Standard: Usability
- IEC 60601-2-10: 2012 (Second Edition), medical electrical equipment -- part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators. (Neurology)
- IEC 62133 Edition 2.0 2012-12, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications
- IEC 62366: 2007 (First Edition) + A1: 2014, Medical devices - Application of usability engineering to medical devices
- IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
April 26, 2018
Heat In A Click % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong 510006 CN
Re: K171821
Trade/Device Name: 2 Face / Face Evolution Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO, OHS, OLP Dated: March 22, 2018 Received: March 26, 2018
Dear Cassie Lee:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171821
Device Name 2 Face / Face Evolution
Indications for Use (Describe)
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 intented for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
| Type of Use (Select one or both, as applicable) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------- |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of the summary prepared: April 26, 2018
1. Submitter's Information
Company Name: Heat In A Click Address: 1975 Tigertail Blvd Dania Florida 33034 USA Phone: 1(954)518-9777 Fax No.: 1(954)320-7984 Contact Person (including title): Guy Levi (CEO) E-mail: hagar@palmmassager.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
4
Heat In A Click Sponsor: 2 Face / Face Evolution, Model: 2 Face / Face Evolution Subject Device: Document Name: FDA 510(k) Submission Report
Type of 510(k): Traditional
Common Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over the Counter Wrinkle Reduction, over-the counter powered light based laser for acne Review Panel: Neurology; General & Plastic Surgery
Trade Name: 2 Face / Face Evolution (Model: 2 Face / Face Evolution)
Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over the
Counter Wrinkle Reduction, over-the counter powered light based laser for acne
Review Panel: Neurology: General & Plastic Surgery
Product code: NFO, OHS, OLP
Regulation Number: 882.5890, 878.4810
Requlation Class: 2
3. Predicate Device Information
| Sponsor | Carol Cole Company | Li-Tek Electronics
Technologies |
|-----------------------|--------------------|------------------------------------|
| Device Name and Model | NUFACE® Plus | LED Phototherapy (PL-120) |
| 510(k) Number | K103472 | K162098 |
| Product Code | NFO | OLP, OHS |
| Regulation Number | 882.5890 | 878.4810 |
| Regulation Class | II | II |
4. Device Description
2 Face / Face Evolution (Model: 2 Face / Face Evolution) is consists of a Main Unit, conductive gel, charger and user manual, it's a multifunctional comprehensive beauty instrument. It's combined with the most effective two kinds of techniques of internationally recognized skin care:
The EMS Mode is intended for facial stimulation for aesthetic purposes. It produces microcurrent discharged through the EMS Mode treatment probe. Microcurrent is an aesthetic modality providing electric current in millionths of an ampere. The EMS mode is indicated for aesthetic facial stimulation and requires the use of conductive gel. 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. It emits energy in the red spectrum for the treatment of periorbital wrinkles. The PHOTON Mode treatment probe is designed for contact with the face. The device continually pulses the light output, and provides 4 kinds of output intensity level.
5. Intended Use / Indications for Use
5
| Sponsor: | Heat In A Click |
|---|---|
| Subject Device: | 2 Face / Face Evolution, Model: 2 Face / Face Evolution |
| Document Name: | FDA 510(k) Submission Report |
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.
6. Test Summary
2 Face / Face Evolution has been evaluated the safety and performance by lab bench testing as following:
- AAMI / ANSI / ISO 10993-5:2009(R) 2014, biological evaluation of medical devices -- part 5: tests for � in vitro cytotoxicity. (Biocompatibility).
- ◆ ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
- � IEC / EN 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
- � IEC 60601-2-11 (First Edition):2010, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- � IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, monitoring and cosmetic/aesthetic use
- ◆ IEC 60601-1-6: 2010 (Third Edition), Medical electrical equipment - Part 1-6 General requirements for safety - Collateral Standard: Usability
- � IEC 60601-2-10: 2012 (Second Edition), medical electrical equipment -- part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators. (Neurology)
- � IEC 62133 Edition 2.0 2012-12, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications
- � IEC 62366: 2007 (First Edition) + A1: 2014, Medical devices - Application of usability engineering to medical devices
- � IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.
7. Comparison to predicate device and conclusion
6
Compare with predicate device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark | NiMH batteries | Li battery | Note 2 | ||
|---|---|---|---|---|---|---|---|---|
| Manufacturer | Heat In A Click | Carol Cole | ||||||
| Company | -- | Average DC current through electrodes when device is on but no pulses are being applied | 0A | 0A | -- | SE | ||
| Device Name | ||||||||
| and Model | 2 Face / Face | |||||||
| Evolution | NuFace® Plus | -- | Number of Output channels | 2 | 1 | -- | SE | |
| Note 2 | ||||||||
| 510(k) Number | K171821 | K103472 | -- | Regulated Current or Regulated Voltage? | Both | Both | -- | SE |
| Product Code | NFO, OHS, OLP | NFO | SE | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | SE |
| Indications for | ||||||||
| Use | 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. | The NuFace® Plus | |||||||
| Facial Toning | ||||||||
| Device is intended | ||||||||
| for facial | ||||||||
| stimulation and is | ||||||||
| indicated for over- | ||||||||
| the-counter | ||||||||
| cosmetic use. | SE | |||||||
| Note 1 | Automatic Overload Trip? | No | No | Yes | SE | |||
| Anatomical | ||||||||
| Sites | Entire Face | Entire Face | SE | Automatic Shut Off | Yes | Yes | Yes | SE |
| Design | Hand-held device | Hand-held device | SE | User Override Control? | Yes | Yes | Yes | SE |
| Target | ||||||||
| Population | Individuals with | |||||||
| periorbital wrinkles, | ||||||||
| Individuals with mild | ||||||||
| to moderate | ||||||||
| inflammatory acne | Individuals seeking | |||||||
| facial simulation for | ||||||||
| aesthetic purposes | SE | Indicator | EMS Mode intensity Indicator lights, Photon Mode working indicator lights, Photon Mode Indicator lights, Charging Indicator | Indicates on/off status, low battery and voltage / current level. | -- | SE | ||
| Note 2 | ||||||||
| Environment of | ||||||||
| Use | Home | Home | SE | Time Range (minutes) | EMS Mode (5 minutes) Photon Mode (5~7 minutes) | 21 minutes | 3 minutes per target area; 2 treatment per week for 6 weeks | SE |
| Note 2 | ||||||||
| Method of Line | ||||||||
| current | ||||||||
| Isolation | Type BF | Type BF | SE | Wavelengths | Red Light (630nm±3nm Wavelength), Blue Light (415nm±3nm Wavelength) | -- | Blue light: | |
| 415nm±3nm | ||||||||
| Red light: | ||||||||
| 630nm±3nm | SE | |||||||
| Note 3 | ||||||||
| Main Unit | ||||||||
| Weight | 200g | 9oz without | ||||||
| charging base | SE | |||||||
| Note 2 | LED power | 0.1 W | -- | 0.1 W | SE | |||
| Dimensions of | ||||||||
| device (inch)[W | ||||||||
| x LxD] | 158mm56mm51.5 | |||||||
| mm | 3"x 5.25"x 1.25" | SE | ||||||
| Note 2 | Energy emitted during the treatment | 1050J | -- | 1080J | SE | |||
| Note 3 | ||||||||
| Housing | ||||||||
| Materials of | ||||||||
| main unit | ABS Plastic & | |||||||
| Stainless Steel | Thermo Plastic | SE | ||||||
| Note 2 | The distance between the LEDs to treatment treatment surface | 2-3 cm | -- | 2-3 cm | SE | |||
| Power Source | DC 3.7V 2200mAh | 4 rechargeable AA | SE | Irradiation area | 26cm²±5% | -- | 30cm²±5% | SE |
| Note 3 |
7
8
| Sponsor: | Heat In A Click |
|---|---|
| Subject Device: | 2 Face / Face Evolution, Model: 2 Face / Face Evolution |
| Document Name: | FDA 510(k) Submission Report |
| Irradiances | Red light: 73.26
mW/cm²±10%
Blue light: 64.10
mW/cm²±10% | -- | Red light: 80
mW/cm² ±10%
Blue light: 65
mW/cm²±10% | SE
Note 4 |
|----------------------------------------|-------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------|--------------|
| Waveform and
Shape | Pulsed Biphasic,
Modulated Square | Pulsed
MonoPhasic,
Modulated Square | -- | SE
Note 3 |
| Maximum
Output Voltage
(+/- 10%) | 310mV @ 500Ω
1.16V @ 2KΩ
5.56V @ 10KΩ | 137 mV @ 500Ω
769 mV @ 2 ΚΩ
3.82 V @ 10 kΩ | -- | SE
Note 3 |
| Maximum
Output Current
(+/- 10%) | 620µA @ 500Ω
580μΑ @ 2KΩ
556μΑ @ 10KΩ | 274μA @ 500Ω
387μΑ @ 2KΩ
283μΑ @ 10kΩ | -- | SE
Note 3 |
| Maximum
Phase Charge | 26.31μC @ 500Ω | 23.06μC @ 500Ω | -- | SE
Note 3 |
| Maximum
Current Density | 0.330mA/cm² @500Ω
(The Minimum
Electrode Size:
2.91cm²) | 0.419
mA/cm²@500Ω | -- | SE
Note 3 |
| Maximum
Power Density | 4.34μW/cm² @500Ω
(The Minimum
Electrode Size:
2.91cm²) | 3.22µW/cm²@500
Ω | -- | SE
Note 3 |
| Pulse Duration | 60ms | 119ms | -- | SE
Note 3 |
| Frequency | 8.333Hz | 8.4Hz | -- | SE
Note 3 |
| Irradiance
source | LED | -- | LED | SE
Note 3 |
| Visible light
LEDs | Yes | Yes | Yes | SE |
| Compliance
with 21 CFR
898 | Yes | Yes | Yes | SE |
| EMC | IEC 60601-1-2 | EN 60601-1-2 | IEC 60601-2 | SE |
| Safety | IEC 60601-1, IEC
60601-2-10 and IEC
60601-2-57 | IEC 60601-1, IEC
60601-2-10 and
IEC 60601-2-57 | IEC 60601-1 and
IEC 60601-2-57 | SE |
Comparison in Detail(s):
Note 1
We find that the combined the predicate devices NuFace® Plus (K103472), LED Phototherapy (PL-120) (K162098) can be equivalent to the subject device per the predicates' 510(k) summary. So the differences will not raise any safety or effectiveness issue.
9
Note 2
Although the Main Unit Weight, Dimensions of device, Housing Materials of main unit, Power source, Number of Output channels, Indicator and Time Range of subject device is different from the predicate devices, they are all compliance with IEC 60601-2-10 requirement for the product. So the differences of function specification will not raise any safety or effectiveness issue.
Note 3
Although the Wavelengths, Energy emitted during the treatment, Irradiation area, Waveform and Shape, Maximum Output Voltage, Maximum Output Current, Maximum Phase Charge, Maximum Current Density, Maximum Power Density, Pulse Duration, Frequency and Irradiance source is a little different from the predicate devices, they are all compliance with IEC 60601-2-57 requirements. So the differences will not raise any safety or effectiveness issue.
Note 4
Although the Irradiances is a little different from the predicate devices, but they are within the deviation range, so the differences will not raise any safety or effectiveness issue.
Final Conclusion:
The subject device "2 Face / Face Evolution" is Substantial Equivalent to the predicate devices.