(62 days)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Not Found
The provided FDA document is a 510(k) clearance letter for an IPL Hair Removal Device. It indicates that the device is substantially equivalent to legally marketed predicate devices.
This document DOES NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in an AI/ML medical device submission.
510(k) clearances for devices like this IPL hair removal device primarily focus on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics and the information submitted demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This often involves performance testing to ensure safety and effectiveness are comparable, but not necessarily adherence to predefined, numerical acceptance criteria for AI/ML performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the requested information relating to AI/ML device performance from the provided text for the following reasons:
- The device is an IPL Hair Removal Device, not an AI/ML-driven diagnostic or treatment device. The 510(k) addresses an Intensed Pulsed Light device, which is a physical apparatus, not a software algorithm.
- The document is a clearance letter, not a detailed study report or clinical trial summary. Clinical trial data or detailed performance studies (especially relating to AI algorithms) are typically far more extensive than what is summarized in the 510(k) clearance letter itself. Such detailed information would generally be found in the full 510(k) submission, which is not provided here.
- There is no mention of an AI algorithm, machine learning, or software-based analysis of medical images/data. The "Indications for Use" describe mechanical hair removal and reduction, not diagnostic tasks that would typically employ AI.
If you have a document pertaining to an AI/ML medical device, please provide that, and I would be happy to analyze it for the requested information.
§ 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.