(57 days)
Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
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.
The provided text is a 510(k) summary for the Luminice device, stating its substantial equivalence to a predicate device (NuBODY Skin Toning Device, K171588). However, this document does not contain any information about acceptance criteria, device performance results from a study, sample sizes, data provenance, expert involvement for ground truth, or MRMC studies.
The document primarily focuses on:
- Device Description: What the Luminice device is, its intended use (body skin stimulation for over-the-counter cosmetic use), and its technical specifications.
- Substantial Equivalence Comparison: A detailed comparison of the Luminice device with its predicate device (NuBODY Skin Toning Device) across various characteristics like regulation number, class, product code, intended use, anatomical sites, technological characteristics, basic unit characteristics, and output specifications.
- Non-clinical Testing: A list of international consensus standards (electrical safety, EMC, additional safety, biocompatibility, software validation) to which the Luminice device has been tested and conformed.
- Conclusion: The device is substantially equivalent to the predicate device based on similar intended uses and technological characteristics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
The document only states that the device has passed certain non-clinical tests (electrical safety, EMC, biocompatibility, software validation) according to specific standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, etc.). These standards define test methods and acceptance limits for specific safety and performance aspects, but the results of these tests (the reported device performance against specific numerical acceptance criteria) are not detailed here. The document also does not mention any clinical studies or studies involving human subjects, nor does it refer to multi-reader multi-case (MRMC) studies or standalone algorithm performance studies. The ground truth establishment methods for any such studies are consequently also not available.
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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.
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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
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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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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 forover-the-counter cosmetic use. Four (4) stainless steel electrodes, fixed on theLuminice 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 mediagel, and it's compatible with NuFACE Gel Primer cleared under K161654. |
| Indications for use: | Luminice is intended for body skin stimulation and is indicatedforover-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 nervestimulator for pain relief | Transcutaneous electrical nervestimulator 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 |
| RegulationSpecialty | 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 |
| TechnologicalCharacteristics | 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 | DifferenceNote 1 |
Table 1- General Comparison Table
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| requires the use of a conductivegel. To promote proper use andprovide feedback to the user,when the device is is contact withthe skin the Luminice device willvibrates and turn on red light. | electrodes, and allows the user toadjust the output for apersonalized comfort level. TheNuBODY device requires the useof a conductive gel. To promoteproper use and provide feedbackto the user, the NuBODY devicebeeps to cue the user to relocatethe NuBODY deviceapproximately 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) | DifferenceNote 2 |
Table 2- Basic Unit Characteristic Comparison
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| Compliance with VoluntaryStandards? | Yes.AAMI/ANSI ES 60601-1,IEC 60601-1-2, IEC60601-2-10, IEC 62133, IEC60601-1-11, ISO 14971 | Yes.IEC 60601-1, IEC 60601-1-2IEC 60529, IEC 60601-2-10ISO 14971, IEC 60601-1-6IEC 62366 | DifferenceNote 3 |
|---|---|---|---|
| Compliance with 21 CFR898? | Yes | Yes | Same |
| Weight (grams) | Approximately 16.5 oz.without power adapter | Approximately 10-14 oz. withoutpower adapter | DifferenceNote 2 |
| Dimensions (mm) [W x H xD] | Approximately 3.5" x 6.9" x5.9" | Approximately 2.75" x6.5" 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 isdelivered in a burst of pulses | Monophasic waveform that isdelivered in a burst of pulses | Same |
| Shape | Voltage Modulated Square | Voltage Modulated Square | Same |
| Maximum Output Voltage(volts) | 28VDC±10% @ open circle410mV±10% @ 500Ω1.7V±10% @ 2KΩ8.1V±10% @ 10KΩ | 28 VDC | Same |
| Maximum Output Current(specify units) | 820μΑ @500Ω | 900μΑ @ 500Ω | DifferenceNote 4 |
| Output Current when notstimulating | <1μΑ | <1μΑ | Same |
| Pulse width (usec) | 60ms | 60ms | Same |
| Max. pulse frequency (Hz)[or Rate (pps)] | 8.3 Hz±10% | 8.3 Hz±10% | Same |
| For interferential modes, only | |||
| a. Beat Frequency (Hz) | No Beat Frequency | No Beat Frequency | Same |
| For multiphasic waveforms, only | |||
| a. Symmetrical phases | Not Multiphasic | Not Multiphasic | Same |
| b. Phase Duration (includeunits) | Not Multiphasic | Not Multiphasic | Same |
| c. (state range, ifapplicable) | Not Multiphasic | Not Multiphasic | Same |
| d. (both phases, ifasymmetrical) | Not Multiphasic | Not Multiphasic | Same |
| Net Charge (µC per pulse) | 49.2μC | 54μC | DifferenceNote 4 |
| Maximum Phase Charge(mC/Burst) | 0.984 | 1.08 | Note 4 |
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| Maximum Current Density,(mA/cm², r.m.s.) | 0.19mA/cm² | 0.468mA/cm² | ||
|---|---|---|---|---|
| Maximum Average PowerDensity, (mW/cm²) | 0.08mW/cm² | 4.18mW/cm² | ||
| BurstMode | (a) Pulses perburst | 20 | 20 | Same |
| (b) Bursts persecond | 8.3 | 8.3 | Same | |
| (c) Burst duration | 2.4 s | 2.4s | Same | |
| (d) Duty Cycle:Line (b) x Line | 19.92s | 20.2s | Similar | |
| ON Time | 60ms | 60ms | Same | |
| OFF Time | 60ms | 60ms | Same |
Differences between New device and Predicate Device:
Note 1:
The proposed device and predicate device have many similarities in technological characteristics except for electrodes, materials and prompt functions. Both of them have passed the biocompatibility tests. For more stability and better contact, the proposed device uses fixed, oval electrodes without sharp horns, and provides more prompt functions than the predicate device (vibration and red contact light prompt). The proposed device has passed the IEC 60601-1, 60601-1-2 tests. Therefore, these differences will not raise any issues of safety or effectiveness.
Note 2:
The automatic shutdown time limit is slightly different between the proposed device (1min) and the predicate device (5min). Because this design doesn't affect the main functions of device, and the proposed device has passed ES 60601-1. IEC 60601-1-2. IEC 60601-1-11 tests. Therefore, this difference will not raise any issues of safety or effectiveness.
The proposed device is different from the predicate device in housing material, weight, dimensions and appearance. Both of them have passed the biocompatibility tests, IEC 60601-1-2 tests. Therefore, these differences will not raise any issues of safety or effectiveness.
Note 3:
The tests performed by our proposed device are slightly different from those of the predicate device. IEC 60529 is the standard for device waterproof level testing, and the waterproof level of our device has been evaluated in the AAMI/ANSI ES 60601-1 test. The predicate device performed usability test according to IEC 60601-1-6 and IEC 62366 standards. The proposed device referred the user manual of the predicate device K171588, and we attached the Labeling of the predicate device K171588 in our submission. Therefore, these differences will not raise any new issues of safety or effectiveness.
Note 4:
The maximum output current, net charge, maximum phase charge of the proposed device are similar to those of the predicate device. And the maximum current density, maximum average power density of the proposed device are lower than those of the predicate device due to they are calculated by different electrode areas. Both of them meet IEC 60601-2-10 tests. Therefore, these differences don't raise any new safety and effectiveness issues.
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4. Non-clinical Testing:
The conclusions drawn from the non-clinical testing below demonstrate that the Luminice is substantially equivalent to the predicate devices K171588. The Luminice has been tested and conforms to international consensus standards:
Electrical safety:
- ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
EMC:
-
IEC 60601-1-2:2014. Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And ● Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
Additional safety testing: -
IEC60601-1-11 Edition 2.0 2015 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;
-
IEC 60601-2-10 Edition 2.1 2016-04: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
-
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 [Including: Corrigendum 1 (2013)];
Biocompatibility testing:
- 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)
Software Validation Testing:
The Luminice's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
5. Conclusions
Based upon comparison to the predicate devices, the Luminice has the same intended uses, with similar technological characteristics as predicate device Luminice is substantial Equivalent to the predicate device K171588.
§ 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).