(85 days)
LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.
The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.
The provided text is a 510(k) summary for an LED Facial Mask, a medical device for over-the-counter use in treating wrinkles and mild to moderate acne. However, it does not contain information about studies that prove the device meets acceptance criteria related to its clinical efficacy.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety data (biocompatibility, electrical safety, eye safety), and software verification and validation. There's no mention of clinical trials or performance studies evaluating the device's effectiveness in treating wrinkles or acne in accordance with specific acceptance criteria beyond general safety and design similarity to other cleared devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them for its intended clinical effects because such information is not present in the provided text. The document primarily details technical and safety compliance, not clinical performance metrics.
§ 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.