(87 days)
IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
The BR2020 IPL hair removal machine is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.
This document is a 510(k) Premarket Notification from the FDA regarding an "IPL hair removal machine." It does not include information about AI/ML device performance, acceptance criteria for an AI/ML model, or a study proving it meets such criteria.
The document discusses substantial equivalence to a predicate device based on:
- Intended Use: Removal of unwanted hair.
- Technological Characteristics: Similar wavelength range, energy medium, energy density, spot size, pulse duration, and pulsing control as predicate devices.
- Performance Data: Biocompatibility testing, electrical safety, eye safety, and software verification and validation.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The device described is an "IPL hair removal machine," which is a hardware device, not an AI/ML software.
The concepts of "acceptance criteria," "test set," "training set," "ground truth," "expert consensus," "MRMC study," and "standalone performance" are relevant to the evaluation of AI/ML software as a medical device, which is not what this document addresses.
§ 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.