(103 days)
IPL Home Use Hair Removal Device is indicated for the 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.
IPL Home Use Hair Removal Device (Model:515) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL)to emit a specific wavelength of the light ranging from 550-1200m and delivers to the skin. The device is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy (below the surface of the surface of the skin), which disables the har follicle preventing further growth, so as to achieve effective hair removal.
This document is a 510(k) Premarket Notification summary for an IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria for a new clinical claim.
Therefore, the provided text does not contain the information requested to describe acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML device. The document states:
- "The clinical test is not applicable, there's no clinical data."
- The non-clinical testing focuses on compliance with electrical safety, EMC, photobiological safety, and biocompatibility standards, and software verification and validation, not on demonstrating the hair removal efficacy against quantitative acceptance criteria.
The prompt assumes the document describes an AI/ML device and its performance study, which is not the case here. This is a traditional medical device (IPL hair removal) 510(k) submission, where substantial equivalence is primarily established through technological comparison and compliance with relevant safety standards.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert ground truth, MRMC studies, or training data, as this information is not present in the provided text.
§ 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.