(273 days)
RevLight is intended for use to provide LED light to the body, and with the large pulsators, facial massage. Depending on the wavelength(s) of light delivered by the detachable Pulsators that are connected to the base unit, RevLight is: 1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies and the control unit. Attachable to the base unit are three sets of Pulsators that deliver the light to the skin as they are moved over the skin surface. The output of the Pulsators ranges from 420-940nm.
This is a 510(k) summary for a medical device and does not contain the detailed study information required to complete the request. The document explicitly states: "RevLight is substantially equivalent in respect to the intended use, design and method of operation to numerous cleared devices". This means that the device was approved based on its similarity to existing cleared devices, not on a new clinical study.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This document refers to substantial equivalence to predicate devices, not specific performance criteria or a study demonstrating the RevLight's independent performance against such criteria.
- Sample size used for the test set and the data provenance: No new test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new clinical study was conducted for the RevLight.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable, as the submission relies on substantial equivalence.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on establishing substantial equivalence to predicate devices for its intended uses, particularly for the treatment of moderate inflammatory acne vulgaris and for providing topical heating.
§ 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.