(57 days)
No
The summary describes a microcurrent device for skin stimulation and does not mention any AI or ML components or functionalities.
No
The intended use states it is for "over-the-counter cosmetic use" and "body skin stimulation," which primarily relate to appearance and sensation rather than the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
Explanation: The device is described as intended for "body skin stimulation" and for "over-the-counter cosmetic use," which points to a cosmetic or therapeutic purpose rather than a diagnostic one. There is no mention of identifying a disease, condition, or health status.
No
The device description explicitly states that the device has "Four (4) stainless steel electrodes, fixed on the Luminice device main body," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "body skin stimulation" for "over-the-counter cosmetic use." This is a physical application to the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details the delivery of electrical impulses to the body via electrodes. This is a physical interaction with the body, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Luminice's function is purely for cosmetic skin stimulation.
N/A
Intended Use / Indications for Use
Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Product codes
NFO
Device Description
Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) stainless steel electrodes, fixed on the Luminice device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body. The Luminice should be used with 510(k) clearance electroconductive media gel, and it's compatible with NuFACE Gel Primer cleared under K161654.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Areas of the body other than the 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
Not Found
Key Metrics
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 24, 2022
Premier North America Inc. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K214100
Trade/Device Name: Luminice Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 22, 2021 Received: December 29, 2021
Dear Doris Dong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214100
Device Name Luminice
Indications for Use (Describe)
Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K214100 |
|---|---|
| Date prepared: | February 12, 2022 |
| Owner: | Premier North America Inc. |
| 3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA | |
| Tel: 404-4928133-11 | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
| 2. Device Description: | |
|---|---|
| Proprietary Name: | Luminice |
| Model: | LUMI536 |
| Regulation Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Device Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Regulation Number: | 21 CFR 882.5890 |
| Product Code: | NFO |
| Device Class: | II |
| Review Panel: | Neurology |
| Device Description: | Luminice is intended for body skin stimulation and is indicated for |
| over-the-counter cosmetic use. Four (4) stainless steel electrodes, fixed on the | |
| Luminice device main body, deliver low level electrical impulses (microcurrent) | |
| to targeted locations on the body. | |
| The Luminice should be used with 510(k) clearance electroconductive media | |
| gel, and it's compatible with NuFACE Gel Primer cleared under K161654. | |
| Indications for use: | Luminice is intended for body skin stimulation and is indicated |
| for | |
| over-the-counter cosmetic use. |
3. Substantial Equivalence to Predicate device:
The proposed Luminice device has the same, or similar, technological characteristics as the NuBODY Skin Toning Device predicate device. The differences between our proposed device and the cleared predicate device listed below do not raise any safety and effectiveness issues.
| Device Descriptions | Luminice
(New Device) | NuBODY Skin Toning Device
(Predicate) | Remark |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | K214100 | K171588 | -- |
| Regulation number | 21CFR 882.5890 | 21CFR 882.5890 | -- |
| Regulation Name | Transcutaneous electrical nerve
stimulator for pain relief | Transcutaneous electrical nerve
stimulator for pain relief | Same |
| Regulatory Class | Class II | Class II | Same |
| Classification Name | Stimulator, Transcutaneous | Stimulator, Transcutaneous | Same |
| | Electrical, Aesthetic Purposes | Electrical, Aesthetic Purposes | |
| Product Code | NFO | NFO | Same |
| Regulation
Specialty | Medical Neurology | Neurology | Same |
| Intended use | Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. | NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. | Same |
| Indications for use | Over-the-Counter cosmetic use | Over-the-Counter cosmetic use | Same |
| Anatomic Sites | Areas of the body other than the face | Areas of the body other than the face | Same |
| Technological
Characteristics | The Luminice is a body skin toning device. Its outer case is injection molded ABS resin. The output contacts consist of stainless steel. The Luminice is powered by a rechargeable lithium ion battery. Luminice produces microcurrent that is discharged through four fixed electrodes. To turn the Luminice on, the on/off button is pressed. Ascending tonal beeps and vibration indicate the Luminice device is on. One to three LED lights illuminate indicating the output intensity level and the unit is ready for use. The four electrodes gently glide over the skin to deliver low-level electrical impulses to targeted locations on the body. The Luminice device electrodes are designed for optimal contact with body skin. The Luminice device delivers microcurrent as a constant monophasic square wave comprised of a burst of (10) positive pulses followed by a burst of (10) negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes, and allows the user to adjust the output for a personalized comfort level. The Luminice device | The NuBODY Skin Toning Device is a body skin toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chrome-plated spherical electrodes. The NuBODY device is powered by a rechargeable lithium ion battery. NuBODY device produces microcurrent that is discharged through four fixed, smooth spherical electrodes. To turn the NuBODY device on, the on/off button is pressed. Ascending tonal beeps indicate the NuBODY device is on. One to three LED lights illuminate indicating the output intensity level and the unit is ready for use. The four spheres gently glide over the skin to deliver low-level electrical impulses to targeted locations on the body. The NuBODY device spheres are designed for optimal contact with body skin. The NuBODY device delivers microcurrent as a constant monophasic square wave comprised of a burst of (10) positive pulses followed by a burst of (10) negative pulses. The microcurrent output continuously alternates between the positive and negative spherical | Difference
Note 1 |
Table 1- General Comparison Table
4
5
| requires the use of a conductive
gel. To promote proper use and
provide feedback to the user,
when the device is is contact with
the skin the Luminice device will
vibrates and turn on red light. | electrodes, and allows the user to
adjust the output for a
personalized comfort level. The
NuBODY device requires the use
of a conductive gel. To promote
proper use and provide feedback
to the user, the NuBODY device
beeps to cue the user to relocate
the NuBODY device
approximately every 5 seconds. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| | Basic Unit Characteristic | Luminice
(New Device) | NuBODY Skin Toning Device
(Predicate) | Remark |
|-----------|----------------------------------------------------|-------------------------------------------|-------------------------------------------|----------------------|
| | 510(k) Number | K214100 | K171588 | -- |
| | Device Name, Model | Luminice (LUMI536) | NuBODY Skin Toning Device | -- |
| | Owner | Premier North America Inc | Carol Cole Company (dba NuFACE) | -- |
| | Power Source(s) | Internal rechargeable Lithium ion battery | Internal rechargeable Lithium ion battery | Same |
| | Method of Line Current Isolation | Type BF | Type BF | Same |
| | Patient Leakage Current
- Normal Condition (μΑ) | N/A - Battery operated | N/A - Battery operated | Same |
| | - Single Fault Condition (μΑ) | N/A - Battery operated | N/A - Battery operated | Same |
| | Number of Output channels: | 1 | 1 | Same |
| | Synchronous or Alternating? | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| | Method of Channel Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| | Regulated Current or Regulated Voltage? | Both | Both | Same |
| | Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| | Automatic Overload Trip? | Not required due to circuit design | Not required due to circuit design | Same |
| | Automatic No-Load Trip? | Yes | Yes | Same |
| | Automatic Shut Off? | Yes | Yes | Same |
| | User Override Control? | Yes | Yes | Same |
| Indicator | On/Off Status? | Yes | Yes | Same |
| Display | Low Battery? | Yes | Yes | Same |
| | Voltage/Current Level? | Yes | Yes | Same |
| | Timer Range (minutes) | Yes (1min) | Yes (5min) | Difference
Note 2 |
Table 2- Basic Unit Characteristic Comparison
6
| Compliance with Voluntary
Standards? | Yes.
AAMI/ANSI ES 60601-1,
IEC 60601-1-2, IEC
60601-2-10, IEC 62133, IEC
60601-1-11, ISO 14971 | Yes.
IEC 60601-1, IEC 60601-1-2
IEC 60529, IEC 60601-2-10
ISO 14971, IEC 60601-1-6
IEC 62366 | Difference
Note 3 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------|
| Compliance with 21 CFR
898? | Yes | Yes | Same |
| Weight (grams) | Approximately 16.5 oz.
without power adapter | Approximately 10-14 oz. without
power adapter | Difference
Note 2 |
| Dimensions (mm) [W x H x
D] | Approximately 3.5" x 6.9" x
5.9" | Approximately 2.75" x
6.5" x 6.0" | |
| Housing Materials &
Construction | ABS and stainless steel | Thermoplastic | |
Table 3- Output Specification Comparison Table
| Output Specifications | Luminice
(New Device) | NuBODY Skin Toning Device
(Predicate) | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------|
| 510(k) Number | K214100 | K171588 | -- |
| Waveform | Monophasic waveform that is
delivered in a burst of pulses | Monophasic waveform that is
delivered in a burst of pulses | Same |
| Shape | Voltage Modulated Square | Voltage Modulated Square | Same |
| Maximum Output Voltage
(volts) | 28VDC±10% @ open circle
410mV±10% @ 500Ω
1.7V±10% @ 2KΩ
8.1V±10% @ 10KΩ | 28 VDC | Same |
| Maximum Output Current
(specify units) | 820μΑ @500Ω | 900μΑ @ 500Ω | Difference
Note 4 |
| Output Current when not
stimulating |