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Found 73 results
510(k) Data Aggregation
(243 days)
The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.
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(263 days)
JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.
The JOVS Electric Stimulation Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It mainly consists of main unit, charging and disinfection base, and power cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has the spring electrode head (electric stimulation) to provide the following function:
The JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.
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(192 days)
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(57 days)
Facial & Body Beauty Device is a hand-held device for over-the-counter aesthetic purposes.
The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging. To use the device, user should place the electrode head on the face and body. The device will automatically shut down after treatment time is over.
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(112 days)
Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.
The Sunny Plus device is a Low Frequency Electric Stimulator that conveys current to the human body through a non-invasive electrode with a frequency of 10Hz. It is composed of the main body, handpiece with electrode tip, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.
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(75 days)
The SX2500 / SX3800 Series devices uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes.
The subject devices, SX2500 & SX3800, under the NFO Product Code, uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. The SX series uses applied accessories like probes, gloves or pads to deliver low electrical current to stimulation of facial tissues for aesthetic purposes.
The SX2500 & SX3800 is a powered microcurrent stimulator that uses electrical energy to stimulate facial tissues for aesthetic purposes. The SX2500 & SX3800 is substantially equivalent to the predicate devices compared in its product code class and has the same IFU. The SX2500 & SX3800 delivers signals independently to specific facial area points by way of channel ports via stainless steel probes and applicators substantially equivalent to the predicate device. The probes, gloves and pads referenced are the only patient contacting parts on the device that is substantially equivalent to the predicate device.
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(3 days)
The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.
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The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.
Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.
This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.
Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.
The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.
All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.
To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.
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(196 days)
CEC101 and EE0101:
Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.
EEI101:
Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.
The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The provided FDA 510(k) clearance letter and summary for the Microcurrent Facial Device (K244004) does not contain information on acceptance criteria for a clinical study or a study proving the device meets performance criteria beyond safety and electrical standards.
This document primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software verification/validation. It explicitly states that "The following performance data were provided in support of the substantial equivalence determination," and lists the aforementioned safety and software tests.
The listed "Indications for Use" for this device are for "facial stimulation for over-the-counter aesthetic use" and "facial, neck and body skin stimulation for over-the-counter aesthetic use." These are aesthetic claims, not medical claims requiring clinical efficacy studies in the same way a device for diagnosing or treating a disease would.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for clinical efficacy
- Sample size used for the test set and data provenance related to clinical efficacy
- Number of experts used to establish ground truth or their qualifications for clinical efficacy
- Adjudication method for a clinical test set
- MRMC comparative effectiveness study or effect size
- Standalone algorithm performance
- Type of ground truth used for clinical efficacy
- Sample size for the training set (for clinical efficacy)
- How ground truth for the training set was established (for clinical efficacy)
The document focuses solely on engineering and safety performance to demonstrate substantial equivalence, not clinical efficacy for aesthetic outcomes. The "performance data" section (Page 15) explicitly lists only biocompatibility, electrical safety, EMC, and software verification/validation as the bases for establishing substantial equivalence.
In summary, for K244004, the acceptance criteria and proof of meeting them are primarily related to safety and functional performance, not clinical efficacy for aesthetic outcomes, as it falls under the "Transcutaneous Electrical Nerve Stimulator For Pain Relief" product code (NFO) but is indicated for aesthetic use. The FDA clearance is based on the device being "as safe, as effective and performs as well as the legally marketed predicate devices" for its intended aesthetic stimulatory purpose, which is proven through the technical and safety evaluations outlined.
If this were an AI/ML medical device, the information requested would be crucial. However, for a microcurrent facial device, the regulatory pathway relies on different types of "performance data."
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(102 days)
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.
The provided FDA 510(k) clearance letter and summary for the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not contain information about acceptance criteria for performance related to its cosmetic claims, nor does it detail a study that proves the device meets such criteria.
The document confirms that clinical performance data and animal studies were not required for this submission. The assessments conducted were primarily for safety and electrical characteristics to ensure the device is as safe and effective as its predicate devices, rather than measuring the cosmetic effect of the device itself.
Therefore, the following information, based on the provided text, will reflect the absence of specific acceptance criteria or studies related to cosmetic performance, and will focus on the safety and technical compliance criteria.
Acceptance Criteria and Study Proving Device Meets Criteria for SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1
The provided FDA 510(k) submission primarily focuses on establishing the substantial equivalence of the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 to predicate devices concerning safety and technical characteristics. The document does not specify acceptance criteria related to its cosmetic effects (e.g., face-lift efficacy) or include a clinical study designed to demonstrate performance against such cosmetic criteria.
The acceptance criteria mentioned are related to electrical and mechanical safety, electromagnetic compatibility, software validation, and biocompatibility, ensuring the device is safe for its intended use as an over-the-counter stimulation device for cosmetic use.
1. A table of acceptance criteria and the reported device performance
Since specific performance acceptance criteria for cosmetic "face-lift" efficacy are not detailed in the provided document, the table below focuses on the reported technical performance and compliance with relevant safety standards. The "Acceptance Criteria" are implied by the standards the device claims compliance with and the comparisons to predicate devices.
| Acceptance Criteria (Implied by Compliance Standards & Predicate Comparison) | Reported Device Performance |
|---|---|
| Electrical Safety & Basic Performance (IEC 60601-1) | Compliant. Bench testing and third-party accredited laboratory evaluation confirmed waveform and output energy characteristics meet intended specifications and national/international standards. |
| EMC (IEC 60601-1-2) | Compliant. Device tested and demonstrated compliance. |
| Home Use Medical Devices (IEC 60601-1-11) | Compliant. Device tested and demonstrated compliance. |
| Nerve & Muscle Stimulators (IEC 60601-2-10) | Compliant. Third-party accredited laboratory evaluated the device in accordance with this standard. Output current, voltage, and current density are within established safety limits and compared favorably to predicate devices. Max output current (760μA@500Ω) and Max current density (0.56mA/cm² @ 500Ω) are significantly lower than standard limits (50mA and 2 mA/cm² respectively). |
| Biocompatibility (ISO 10993-1, -5, -10, -12, -23) | Compliant. Biocompatibility evaluation performed for patient-contacting components (housing materials, spheres), showing no adverse skin reactions. |
| Ingress Protection (IEC 60529) | Compliant. Device tested and demonstrated compliance. |
| Usability Engineering (IEC 62366) | Compliant. Device tested and demonstrated compliance. Feedback mechanisms (tactile and sound) address lack of visual indicator. |
| Risk Management (ISO 14971) | Compliant. Device tested and demonstrated compliance. Substantial reduction in maximum power density compared to some predicates minimizes thermal/electrical injury risk. |
| Software Verification & Validation | All testing conducted as recommended by FDA guidance. Software classified as "basic" level of concern. |
| Maximum Output Voltage | 25.2VDC (No Load). Lower than some predicates (28VDC), considered safe. |
| Maximum Output Current | 760μA@500Ω. Falls between predicate devices (400 μA and 900 μA) and well below the IEC 60601-2-10 limit of 50mA. |
| Maximum Output Current Density | 0.56mA/cm² @ 500Ω. Slightly higher than some predicates but significantly lower than Predicate Device 3 (8.8 mA/cm²) and the IEC 60601-2-10 noted trigger level of 2 mA/cm². |
| Maximum Power Density | 151 μW/cm². Significantly lower than Predicate 2 (4.18 mW/cm²) and Predicate 3 (39,600 μW/cm²), considered a safety advantage. |
| Maximum Phase Charge | 45.6 μC@500Ω. Higher due to longer pulse width, but offset by lower output current and balanced biphasic waveform for zero net output, operating within safety limits. |
2. Sample size used for the test set and the data provenance
The document specifies "production-equivalent devices" were used for bench testing. It does not provide a specific sample size (N=?) for these test devices.
The data provenance is based on internal testing conducted by GESKE Beauty Tech GmbH and evaluation by a "third-party accredited laboratory." The country of origin for these tests is not explicitly stated, but the submitter is based in Berlin, Germany. The testing described is prospective in nature, as it involves newly conducted tests on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for any performance claims related to cosmetic efficacy. The "ground truth" for the technical and safety performance is established by compliance with international standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices, which are assessed by regulatory bodies. The qualifications of personnel conducting the internal and third-party laboratory tests are implied by their accreditation to perform such standards-based evaluations, but specific expert details are not provided.
4. Adjudication method for the test set
No adjudication method (e.g., 2+1, 3+1) is described, as the testing focuses on objective measurements against engineering specifications and compliance with recognized safety standards, rather than subjective interpretation or consensus-based clinical assessments.
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
No MRMC comparative effectiveness study was conducted. The device is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study focused on cosmetic efficacy (e.g., "face-lifting" ability) was not conducted or reported. The "standalone" performance here refers to the device's technical specifications and safety compliance, which were evaluated in bench tests and by a third-party laboratory without human interaction for performance claims beyond safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is primarily defined by:
- Compliance with international standards: (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, IEC 60529, IEC 62366, etc.) for electrical safety, EMC, biocompatibility, usability, and risk management.
- Technical specifications: Measurements of output characteristics (voltage, current, density, waveform) against design tolerances.
- Substantial equivalence to predicate devices: Comparing its technical characteristics and safety profile to legally marketed devices.
There is no mention of ground truth established by expert consensus, pathology, or cosmetic outcomes data for the device's "face-lift" claims in this 510(k) summary.
8. The sample size for the training set
This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable.
9. How the ground truth for the training set was established
This information is not applicable as the device does not utilize a training set in the context of AI/machine learning.
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(186 days)
The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.
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I apologize, but the provided FDA 510(k) clearance letter for the Préime DermaFacial (MicroT) device does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.
This type of FDA clearance letter primarily states that the device has been found substantially equivalent to a predicate device and outlines regulatory obligations. It does not typically detail the specific performance studies, acceptance criteria, or expert qualifications that were submitted as part of the 510(k) application.
To answer your questions, I would need to access the full 510(k) submission document or a summary of safety and effectiveness, which is not included in the provided text.
Therefore, I cannot provide the requested table and detailed information based solely on this document.
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