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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.

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