(120 days)
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.
Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles
Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction. The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles. Microcurrent to target facial stimulation. Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software. Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons. Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.
Here's an analysis of the acceptance criteria and supporting study for the Luna 4 plus device, based on the provided FDA 510(k) summary:
The document provided primarily focuses on establishing "substantial equivalence" of the Luna 4 plus to existing predicate devices, rather than defining explicit acceptance criteria and then presenting a study to prove meeting those criteria in the traditional sense of a clinical trial for a novel device. The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate devices through conformance to recognized standards and comparative testing.
The "study" that proves the device meets "acceptance criteria" (i.e., is substantially equivalent to predicates) is a combination of:
- Non-clinical testing: Electrical safety, EMC, and biocompatibility, as per applicable standards.
- Lab bench performance testing: Characterization of electrical stimulation output, including Anti-Shock System performance and overload conditions.
- Usability studies: To demonstrate substantial equivalence given new indications.
1. A table of acceptance criteria and the reported device performance
Since explicit "acceptance criteria" in the format of specific numerical thresholds tied to a single study result are not provided, I will construct a table reflecting the key equivalency demonstrations and comparisons made against the predicate devices. The "reported device performance" will be the "Subject Device" values from the Substantial Equivalence Comparison Table, along with notes on safety and efficacy from the "Conclusion" and "Comparison in details" sections.
| Feature Area | Implicit Acceptance Criterion (Demonstrate Substantial Equivalence to Predicate) | Reported Device Performance (Luna 4 plus) |
|---|---|---|
| Regulatory Information | ||
| Regulation Number | Comparable regulatory classification for similar intended uses. | 878.4810 (Laser surgical instrument), 882.5890 (Transcutaneous Electrical Nerve Stimulator). Different from some predicates but within acceptable classifications for its functions. |
| Intended Use | Indications for facial stimulation and periorbital wrinkle treatment should be similar to predicates. | 1. Red + IR light intended to treat periorbital wrinkles. 2. Microcurrent intended for facial stimulation. Similar to predicates. |
| Safety Mechanism | Possess safety mechanisms (e.g., thermal, electrical protection) equivalent to or better than predicates. | Thermal sensor and heat stabilizer (prevents overheating above 42-43°C). Anti-Shock system (monitors voltage on feedback resistor to ensure stable current). Different from some predicates but detailed to demonstrate safety. |
| Device Characteristics | ||
| Application Area | Face. | Face. Same as predicates. |
| Use Environment | Home Use, lay users. | Home Use, lay users. Same as predicates. |
| Power Source | Internal rechargeable battery. | Internal rechargeable Lithium battery. Same as predicates. Tested to IEC 62133-2. |
| Software/Firmware/Control | Presence of control software. | Yes. Same as predicates. |
| Patient Override Control | User control over device operation. | Yes. Same as predicates. |
| Microcurrent Function | ||
| Electrical Characteristics | Microcurrent characteristics (e.g., waveform, pulse width, output voltage/current, frequency) should be safe and effective, and differences adequately justified/tested. | Pulsed monophasic, alternating polarity, charge-balanced waveform; Modulated square shape; Pulse width 290 µs; Max RMS Output Voltage 0.28V @500Ω; Max RMS output Current 560μA @500Ω; Max Net Charge 0 µC (charge-balanced). Frequency Range 46Hz. Different from predicates but evaluated via lab bench performance testing to IEC 60601-2-10 to ensure safety and effectiveness, acknowledging lower output power density than one predicate. |
| LED/NIR Light Function | ||
| Optical Characteristics | LED wavelength and power density suitable for stated indications and comparable to predicates. | RED light: 633nm±10nm; Red+IR: 633±10nm / 850nm±10nm. Optical Power Density RED+IR: 63 mW/cm². Differences in wavelength and power density from predicates but supported by usability report and bench evaluation for safety and efficacy. |
| Compliance & Standards | ||
| Biocompatibility | Compliance with relevant ISO 10993 standards. | ISO 10993-5, ISO 10993-10, ISO 10993-23. Similar to predicates. |
| Electrical Safety | Compliance with relevant IEC 60601 standards. | IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-2-57. Similar to predicates. Performance testing of Anti-Shock System and under overload conditions also performed. |
| EMC | Compliance with IEC 60601-1-2. | IEC 60601-1-2. Same as predicates. |
| 21 CFR 898 | Compliance with 21 CFR 898 performance standards. | Yes. Same as predicates. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in terms of a clinical or image dataset. The testing primarily involved non-clinical lab-based evaluations:
- Electrical safety, EMC, and biocompatibility: Tested against applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993 series). This typically involves a single or small number of device units.
- Lab bench performance testing: Characterization of electrical stimulation, Anti-Shock System, and overload conditions. This would also involve a small number of physical devices.
- Usability studies: These are mentioned, but no specifics on sample size (number of users) or study design (e.g., prospective, retrospective, country of origin) are provided.
Therefore, there isn't a "sample size for the test set" in the context of an AI/algorithm performance study using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/provided in the document as it does not describe a study involving expert-derived ground truth for a test set of patient data, which is typical for AI/algorithm performance evaluations. The evaluations performed are engineering-based and comparative.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as there is no described test set requiring expert adjudication for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device (Luna 4 plus) is a physical device for topical aesthetic treatment and does not involve "human readers" interpreting medical cases or AI assistance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical, user-operated aesthetic device. While it contains integrated software ("integral software" to control microcurrent and the "Anti-Shock system"), this is part of the device's functional control, not a standalone diagnostic or interpretative algorithm. Therefore, a "standalone algorithm-only performance study" as typically understood for AI/ML devices is not applicable/provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used for AI/ML models is not directly applicable here. The "truth" for this device's evaluation is primarily based on:
- Reference standards: Adherence to national and international engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series).
- Benchmarking against predicate devices: Demonstrating similar or improved safety and functionality compared to legally marketed devices.
- Physical measurements: E.g., optical power density, electrical output characteristics.
For the usability studies mentioned, the "ground truth" would likely be user feedback or successful completion of tasks, but details are not provided.
8. The sample size for the training set
This information is not applicable/provided as the document does not describe the development of an AI/ML model that would require a "training set." The integral software is likely rule-based or control-loop driven rather than a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
{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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
August 20, 2024
Foreo Inc. % Danijela Domljanovic Consultant DD Consulting 401-4080 Living Arts Drive Mississauga, ON L5B 4N3 Canada
Re: K241102
Trade/Device Name: Luna 4 plus Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, NFO Dated: April 16, 2024 Received: April 22, 2024
Dear Danijela Domljanovic:
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 (the 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 available 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
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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).
{2}------------------------------------------------
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.08.20
19:33:18 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K241102
Device Name Luna 4 plus
Indications for Use (Describe)
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.
Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K241102 - LUNA 4 plus 510(k) Summary
| Date Prepared: | 08/20/2024 |
|---|---|
| 510(k) Submitter: | FOREO, Inc.1525 E. Pama LaneLas Vegas, NV 89119 |
| Contact: | Danijela DomljanovicE: regulatoryna@foreo.comP: 647-928-6919 |
| Device Names: | |
| Device Trade/ Proprietary Name: | Luna 4 plus |
| Common or Usual Name: | Luna 4 plus |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology |
| Regulation Number: | 21 CFR 890.481021 CFR 882.5890 |
| Product Code: | OHS, NFO |
Predicate Device:
The legally marketed predicate devices to which FOREO, Inc. is claiming equivalence for over-the-counter use:
| 510(k) Number: | K162652 |
|---|---|
| Manufacturer: | Guangzhou LETA Testing Technology Co., Ltd. |
| Product Code: | OHS, NFO, OLP |
510(k) Number: K201906 Carol Cole Company dba NuFACE Manufacturer: Product Code: NFO
| 510(k) Number: | K212155 |
|---|---|
| Manufacturer: | Theragun, Inc |
| Product Code: | OHS, OLP, IRC |
{5}------------------------------------------------
Device Description:
Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction
The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles.
Microcurrent to target facial stimulation
Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software.
Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons.
Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.
Intended Use:
Luna 4 plus is a Near-Infrared Heated Cleansing Device with Red LED/NIR light & Microcurrent Massage
Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles
Technological Characteristics:
LUNA 4 plus is substantially equivalent to that of its technological characteristics remain unchanged.
Non-Clinical Testing:
To establish substantial equivalence to the predicate devices, LUNA 4 Plus was tested to the applicable standards for electrical safety, EMC, and biocompatibility, as listed in the Substantial Equivalence Comparison Table below. Additionally, LUNA 4 Plus underwent lab bench performance testing to characterize its electrical stimulation output, including performance testing of the Anti-Shock System and performance under overload conditions. Usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications.
{6}------------------------------------------------
Performance Standards:
Luna 4 plus is substantially equivalent to that of its predicates and complies to FDA performance standards set forth in 21 CFR §898.
Product Safety and EMC performance testing was conducted for the following aspects:
- ി . Electrical and Constructional Safety in accordance with IEC 60601-1
-
- Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2
Thus, with respect to Safety and EMC, Luna 4 plus is substantially equivalent to its predicates.
{7}------------------------------------------------
Table 1: Substantial Equivalence Comparison Table
| Features | Subject Device | Predicate | Predicate Device | Predicate Device | Remarks |
|---|---|---|---|---|---|
| Regulatory Information | |||||
| Device Name | Luna™ 4 plus | EP-300 | TheraFace LED | Nuface Trinity ELEPlus Pro | / |
| 510(K) No. | Applying | K162652 | K212155 | K201906 | / |
| RegulationNumber | 878.4810882.5890 | 882.5890 | 878.4810 | 882.5890 | Different |
| Regulationname | Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology | TranscutaneousElectrical NerveStimulator for PainRelief | Laser surgicalinstrument for usein general andplastic surgeryand in dermatology | TranscutaneousElectrical NerveStimulator for PainRelief | Different |
| RegulatoryClass | II | II | II | II | Same |
| Product Code | OHS, NFO | OHS,NFO,OLP | OHS, OLP, IRO | NFO | Similar |
| Intended Use | 1.The Red + IR light isintended to treatperiorbital wrinkles2.The microcurrent isintended to treatfacial stimulation | (1) The EMS mode isindicated for facialstimulation;(2) The Photon mode:The red light isintended for thetreatment ofperiorbital wrinklesand the blue light isintended for thetreatment of the mildto moderateinflammatory acne | The device canwork in multiplefunction modes asfollowing withdifferent indicationfor use:1.The red light isintended to treatperiorbitalwrinkles.2.The blue light isintended to treatmild to moderateinflammatory acne.3.The Red + IR isintended to treatperiorbitalwrinkles. | The Trinity ELE PlusPro devices areintended for facialstimulation andindicated for over-the-countercosmetic use. | Similar |
| Indications forUse | OTC Cosmetic Use | OTC Cosmetic Use | OTC Cosmetic Use | OTC Cosmetic Use | Same |
| Safetymechanism | Thermal sensor andheat stabilizer: Thesemeasure the skintemperature, stabilizethe heat energy andprevent overheating.When the skintemperature reaches42°C - 43°C, thestabilizer willautomatically stopemitting heat, untilthe skin temperaturelowers enough for thestabilizer to resumeheating.Anti-Shock system:Detect the currentthrough the skin bymonitoring voltage onthe feedback resistor,and feedback to themicroprocessor toensure the currentkeeps relatively stableand smooth. | Unknown | The device has anautomatic resetthermallimiter that shutsoff the device topreventoverheating andfire | Unknown | Different |
| Device Characteristics | |||||
| Apply Parts | Face | Face | Face | Face | Same |
| Treatmentregimen | Yes (1-4 min)(adjustable) | Yes (10 mins) | Red light: 5 - 7minutes pertreatment zoneRed+IR: 5 - 7minutes pertreatment zone | Yes (21 mins) | Different |
| UseEnvironment | Home Use, lay users | Home Use, lay users | Home Use, layusers | Home Use, layusers | Same |
| Power Source(s) | Internal rechargeableLithium battery | Internal rechargeableLithium battery | InternalrechargeableLithium battery | InternalrechargeableLithium battery | Same |
| Maximumcharging time | 2 hours | Unknown | 1 hour | 12 hours | Different |
{8}------------------------------------------------
{9}------------------------------------------------
| Indicator forDisplay | On/off | Yes | Yes | Yes | Yes | Same | |
|---|---|---|---|---|---|---|---|
| Low-battery | Yes | Yes | Yes | Yes | Same | ||
| Currentlevel | Yes | Yes | Yes | Yes | Same | ||
| RegulatedCurrent orRegulatedVoltage | Regulated Voltage | Regulated Voltage | Both | Both | Similar | ||
| Software/Firmware/ control | Yes | Yes | Yes | Yes | Same | ||
| AutomaticOverload Trip | Not required due tocircuit design | Yes | Yes | Not required dueto circuit design | Similar | ||
| Automatic ShutOff | Yes | Yes | Yes | Yes | Same | ||
| Micro current Function | |||||||
| Electrodes | 1 | 2 | N/A | 1 | Similar | ||
| Method of linecurrentisolation | Type BF | Type BF | N/A | Type BF | Same | ||
| Patient leakage current | |||||||
| Normalcondition | N/A-Battery operated | N/A-Battery operated | N/A | N/A-Batteryoperated | Same | ||
| Single faultcondition | N/A-Battery operated | N/A-Battery operated | N/A | N/A-Batteryoperated | Same | ||
| Number ofoutput channels | 1 | 1 | N/A | 1 | Same | ||
| Synchronous oralternating | N/A-1 Output channel | N/A-1 Output channel | N/A | N/A-1 Outputchannel | Same | ||
| Method ofchannelisolation | N/A-1 Output channel | N/A-1 Output channel | N/A | N/A-1 Outputchannel | Same | ||
| Patient overridecontrol | Yes | Yes | N/A | Yes | Same | ||
| Waveform | Pulsed monophasic,alternatingpolarity,charge-balanced | Pulsed Biphasic | N/A | Pulsed Biphasic | DifferentNote 2 |
{10}------------------------------------------------
| Waveformshape | Modulated square | Rectangular | N/A | Modulated square | DifferentNote 2 |
|---|---|---|---|---|---|
| Pulse widthrange | 290 µs | 4ms | N/A | Varies w/Frequency(60 msec @8.33Hz) | DifferentNote 2 |
| Maximum RMSOutput Voltage | 0.28V @500Ω1.11V @2KΩ5.50V @10KΩ | 1.49V @500Ω2.48V @2kΩ10.6V @10kΩ | N/A | 208 mV @ 500 Ω840 mV @ 2 kΩ4.3 V @ 10 kΩ | DifferentNote 2 |
| Maximum RMSoutput Current | 560μA @500Ω555μΑ @2ΚΩ552μA @10KΩ | 2.98mA @500Ω1.24mA @2kΩ1.06mA @10kΩ | N/A | 297 μΑ @ 500 Ω299 μΑ @ 2 κΩ301 μΑ @ 10 κΩ | DifferentNote 2 |
| Maximum RMSCurrent Density | 1.37 mA/cm² @500 Ω | 0.524mA/cm² @500 Ω | N/A | 1.165 mA/cm²@10K Ω | DifferentNote 2 |
| Maximum RMSPower Density | 0.38 mW/cm² @500 Ω | 0.216 mW/cm² @500 Ω | N/A | 3.525 mW/cm²@10K Ω | DifferentNote 2 |
| FrequencyRange | 46Hz | 60Hz | N/A | 0.3 — 50 Hz(Default 8.3 Hz) | DifferentNote 2 |
| Outputtolerance | +/- 10% (RMS) | unknown | N/A | +/- 10% (RMS) | Same |
| Maximum NetCharge | 0 µC(charge-balanced) | 0 µC | N/A | N/A - BatteryOperated | DifferentNote 2 |
| Maximum RMSphase chargeper burst | 0.16μC@ 500Ω | Unknown | N/A | 18.17 μC @ 10K Ω | DifferentNote 2 |
| Maximum RMScharge density | 0.39μC/cm2 | Unknown | N/A | Unknown | DifferentNote 2 |
| Output RMScurrent whennot simulating | <1 μΑ | Unknown | N/A | Unknown | DifferentNote 2 |
| For interferential modes, only | |||||
| a. BeatFrequency(Hz) | No Beat Frequency | Unknown | N/A | No Beat Frequency | Same |
| For multiphasic waveforms, only | |||||
| Symmetricalphases | Not Multiphasic | Unknown | N/A | Not Multiphasic | Same |
| b. PhaseDuration(include units)c. (state range, if applicable)d. (both phases, if asymmetrical) | No Beat Frequency | Unknown | N/A | No Beat Frequency | Same |
| Burst mode information | |||||
| a. Pulses perburst | 2 | Unknown | N/A | 20 | DifferentNote 2 |
| b. Pulses persecond | 100 | Unknown | N/A | varies w/Frequency(8.3 @8.33Hz) | DifferentNote 2 |
| c. Burstduration (sec) | 0.02 | Unknown | N/A | Varies w/Frequency(2.4 @ 8.33Hz) | DifferentNote 2 |
| d. Duty Cycle(%) | NA | Unknown | N/A | 50 | DifferentNote 2 |
| On time(sec) | 372 μs | Constant | N/A | Varies w/Frequency(60ms @ 8.33Hz @50% Duty Cycle) | DifferentNote 2 |
| Off time(sec) | 10.12 ms | None | N/A | Varies w/Frequency(60ms @ 8.33Hz @50% Duty Cycle) | DifferentNote 2 |
| For LED Red and NIR Light Irradiation function | |||||
| Visible LEDWavelength | RED light:633nm±10nmRed+IR: 633±10nm /850nm±10nm | Red-light:630±10nmBlue light:415±10nm | Red light:633nm±10nmRed+IR: 633±10nm/830nm±10nm | N/A | DifferentNote 3 |
| Optical PowerDensity | RED+IR:63 mW/cm² | Red light:80 mW/cm2Blue light:50mW/cm2 | Red light:73±5 mW/cm²Red+IR:73±5/55±5mW/cm² | N/A | DifferentNote 3 |
| Additional Features | |||||
| Weight | 150g | 125g | 230g | 180g | DifferentNote 4 |
| Dimensions(mm) | 8238102 mm | 140.5 x 61 x 76 mm | 1406555 mm | 1277625mm | DifferentNote 4 |
| Housingmaterial andconstruction | Body-safe silicone,ABS plastic, copper,glass, gold, zinc alloy | Console: ABS plastic | PC Plastic &Stainless Steel | ABSThermoplastic,Chromium | Similar |
| User interface | Power button on/OffDeep cleansing modebuttonRegular cleansingmode button | Power button on/OffSwitch buttonShift Adjust IntensityLCD ScreenPhoton Light | Power ButtonPercussive TherapyButtonRing buttonRED+IR LED Ring | multi-functionbutton on/offBOOST buttonRelease ButtonPower down/upbutton | Similar |
| Environmentfor operating | Temperature:5 ~ 40° CRelative humidity:40%~ 80% | Temperature:5~ 40° CRelative humidity:<93% RH | Temperature:0 ~ 40° CRelative humidity:<93% RH | Temperature:10 ~ 40° CRelativehumidity:30~75%rH | Similar |
| Environmentfor storage | Temperature:-10 ~ 50° CRelative humidity:30%~ 80% | Temperature:-25° C ~ 50° CRelative humidity:10~95% RH | Temperature:-25 ~ 50° CRelative humidity:10~95% | Temperature: -10 | Similar |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Similar |
| Electrical Safety | IEC 60601-1IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 60601-2-57 | IEC 60601-1IEC 60601-2-10 | IEC 60601-1,IEC 60601-1-11IEC 60601-2-57IEC 62471 | IEC 60601-1 | Similar |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Compliancewith 21 CFR 898 | Yes | Yes | Yes | Yes | Same |
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
Comparison in details
Note 1:
The power supply for the subject device is different from that of the predicate device, however the lithium battery of the subject device has been tested under standard IEC 62133-2, so this difference should not raise any safety/effectiveness questions.
Note 2:
Though the electrical microcurrent stimulation characteristics of the LUNA 4 Plus (including effective area, pulse width range, burst characteristics, and total output power density) differ slightly from the predicate devices, these differences are intended to provide improved user experience and do not significantly affect the subject device's safety and effectiveness relative to the predicates. In particular, the LUNA 4 Plus' output power density is lower than the secondary predicate (K201906), and adequate electrical safety and performance testing were conducted according to applicable standards for nerve and muscle stimulators (including IEC 60601-2-10) as well as lab bench performance evaluation.
Note 3:
Although differences exist for LED wavelength and Optical Power Density, additional usability report and bench evaluation are performed to ensure its safety and effectiveness.
Note 4:
Although the appearance, dimensions, and environment storage are different between the subject and predicate device, these differences have no impact and do not raise any safety/effectiveness problems.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807 and based on the relative information provided in this premarket notification, we conclude the LUNA 4 plus is substantially equivalent to the EP-300, TheraFace LED and Nuface Trinity ELE Plus Pro with regards to safety and effectiveness.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.