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Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)

Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.

The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base 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 device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:

a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718)
b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718)
c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.

The provided text is a 510(k) Summary for a Micro-current Facial Beauty Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards. It does not describe the acceptance criteria and a study proving the device meets those acceptance criteria for efficacy or performance in terms of its intended medical use (treatment of facial wrinkles and mild to moderate inflammatory acne).

The "Performance Data" section primarily addresses safety and electrical compliance, not clinical efficacy or diagnostic accuracy. This is typical for Class II devices seeking 510(k) clearance, where substantial equivalence often relies on demonstrating similar safety and performance characteristics to previously cleared devices rather than new clinical trials demonstrating efficacy against specific metrics for the stated indications.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those acceptance criteria for its intended clinical use from the given document.

The document states:

• Intended Use: "Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne."
• Performance Data provided: Biocompatibility Testing, Electrical Safety, and Software Verification and Validation.

There is no mention of a study involving human subjects or data related to the actual treatment of wrinkles or acne using this device. The document focuses on demonstrating that the device is similar enough to existing cleared devices in terms of its technical specifications and general safety.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria for Efficacy/Performance: The document does not define specific clinical acceptance criteria (e.g., percentage reduction in wrinkles, improvement score for acne) that the device must meet to demonstrate efficacy for its intended use.
2. Study Proving Efficacy/Performance: There is no description of a clinical study or performance study that measures the device's ability to treat facial wrinkles or mild to moderate inflammatory acne.
3. Specifics of a Clinical Study (Sample Size, Ground Truth, Experts, MRMC): Since no such study is described, all related points (sample size, data provenance, number/qualifications of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, training set details) are absent.

What the document does provide in terms of "acceptance criteria" is largely related to safety and regulatory compliance:

• Biocompatibility: Adherence to ISO 10993 standards (e.g., passing tests for in vitro cytotoxicity, skin sensitization, irritation).
• Electrical Safety: Compliance with various IEC 60601 series standards for medical electrical equipment (general safety, electromagnetic disturbances, home healthcare environment, nerve/muscle stimulators, battery safety).
• Software Verification and Validation: Meeting software requirement specifications and mitigating hazards to acceptable risk levels (consistent with a "Basic Documentation Level of concern").

In conclusion, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, supported by engineering, electrical, and biocompatibility testing, rather than new clinical efficacy data for the treating indications.

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Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne.

The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base 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 device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:

a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne.
b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is class I and not need for 510K, and the hot compress is not for medical purpose).

The provided document is a 510(k) Premarket Notification from the FDA for a Micro-current Facial Beauty Device. The document focuses on demonstrating substantial equivalence to predicate devices, and therefore, it does not contain information about a study proving the device meets specific acceptance criteria related to its clinical efficacy (i.e., treatment of facial wrinkles and mild to moderate inflammatory acne) through a comparative effectiveness study with human readers or an algorithm-only performance study.

The performance data included in the document relates to:

• Biocompatibility Testing: Ensuring the materials in contact with the body are safe.
• Electrical Safety: Confirming electrical safety standards are met.
• Eye Safety: Assessing the safety of the light emitted for the eyes.
• Software Verification and Validation: Demonstrating that the device's software functions as intended and addresses potential risks.

These tests are primarily for device safety and functional performance, not clinical efficacy in the way a clinical trial for a treatment would be conducted.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for clinical efficacy.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for clinical efficacy, as such studies are not described for this type of 510(k) submission.
3. Sample size for the training set and how ground truth was established for the training set, as this is not an AI/ML device where a training set with established ground truth would be described for clinical performance.

The document states: "Performance data supports that the device is safe and as effective as the predicate devices for its intended use." However, this effectiveness claim is based on the substantial equivalence argument (similar technological characteristics to other cleared devices with similar indications), rather than new clinical efficacy data for this specific device.

In summary, the provided document does not contain the information required to answer your specific questions related to the clinical performance and acceptance criteria for the treatment of facial wrinkles and mild to moderate inflammatory acne, as it's a 510(k) submission focused on substantial equivalence based on technical and safety data.

Ask a specific question about this device