(289 days)
The Cheveux Diode Laser System is indicated for:
- Hair Removal
- Permanent hair reduction
- Treatment of benign vascular lesions
- . Treatment of benign pigmented lesions
- Treatment of Leg Veins
- . Treatment for pseudofolliculitis barbae
The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.
The 810nm Diode Laser System consists of a console that houses the power supply, control electronics and user interface and a diode laser handpiece. The device is activated by means of a footswitch and a handswitch.
The Laser System is designed for use in a clinic, which shall be a clean, dry and wellventilated room with a door.
The provided text is a 510(k) summary for a medical device called "810nm Diode Laser System." It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets performance claims through clinical studies or AI algorithm performance. The "tests" mentioned are non-clinical and relate to electrical safety, EMC, and radiation safety, which are regulatory compliance tests, not performance studies as would be conducted for an AI/ML device or a device requiring clinical evidence.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states:
- "The 810nm Diode Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device."
- "The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, test data and report information are included in this submission. IEC 60601-1, EN 60601-1-2 : 2015 (EN 55011: 2009+ A1: 2010), EN 60601-1-2 : 2015, EN 61000-3-3, EN 61000-3-2."
These are standards for basic safety and essential performance, not clinical performance or efficacy studies. The substantial equivalence is based on similar technological characteristics and non-clinical safety/EMC standards, not on a study proving specific performance metrics like those for an AI/ML device (e.g., sensitivity, specificity, or improvement in human reader performance).
§ 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.