(221 days)
myLEDmask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.
MyLEDmask is a device used to perform photobiomodulation (based on lightemitting diode (LED) light) on the face and neck. Light radiates from the inner surface of the device onto the face and neck. This light is generated by LEDs with two different visible spectrum wavelengths: red (630 nm) and near-infrared (850 nm). 3 Care programs (LEDs activation duration) based on 3 skin phototypes (skin tone) are available. - Phototype 1 Fair Skin - - Phototype 2 Moderately Dark Skin - -Phototype 3 Dark Skin At the end of care duration, device will automatically switch off It is operated by a microcontroller and powered by rechargeable batteries with an external independent Charger To prevent irradiation of LED lights to eyes during the treatment, MyLEDmask has protective eye-shield which blocks light energy from LEDs.
The provided text is a 510(k) premarket notification for a medical device called "myLEDmask." This document is used by the FDA to determine if a new device is "substantially equivalent" to an already legally marketed device (predicate device).
Based on the information provided, the "myLEDmask" does not rely on clinical performance data for its clearance. The document explicitly states:
"No clinical Performance data are included in this submission. However, based on FDA guidance, usability has been evaluated with panel of representative users." (Page 6, Section 9)
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information cannot be extracted from this document, as a clinical performance study was not performed or submitted for this 510(k) clearance.
The clearance is based on:
- Substantial Equivalence: The device is considered substantially equivalent to predicate devices based on:
- Same Indications for Use.
- Same technological and technical characteristics (Principle of operation).
- Results of non-clinical tests.
The document highlights the device's technical specifications and compares them to several predicate devices. This comparison serves as the basis for demonstrating substantial equivalence rather than a new clinical study.
§ 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.