(24 days)
The easy Claire is an over-the-counter medical device intended for the treatment of full face wrinkles.
The easy Claire is a device that allows the emission of 630nm LED light and 850nm IRED light on the face, which induces photobiological effects for the treatment of facial wrinkles. The easy Claire is an over-the-counter device and consists of a collection of 99 LEDs (630nm) and 99 IREDs (850nm) for the treatment of facial wrinkles. Users place the lightweight mask over the face and use the touch switch button to operate the easy Claire. The device will automatically turn off after treatment. To prevent irradiation of LED lights to the eye during the treatment, easy Claire has a protective eye-shield that blocks light from LEDs. The device is powered by the internal rechargeable lithium-ion battery which is recharged by the specified external adapter with Input AC 100-240V, 50/60Hz, and Output DC 5V, 2A.
The provided text is a 510(k) summary for the medical device "easy Claire," a light-based device intended for the treatment of full face wrinkles. The document details the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or performance data from a study directly comparing the device's efficacy against such criteria.
The "Performance Data" section (Page 5) lists only non-clinical tests related to safety and electrical standards (e.g., IEC, ISO standards, risk management). It does not include any clinical study results demonstrating the device's effectiveness in wrinkle reduction or against any quantitative performance metrics for efficacy.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance study results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses solely on establishing substantial equivalence based on technological characteristics and safety standards, not on direct clinical efficacy data against predefined acceptance criteria for wrinkle reduction.
§ 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.