(53 days)
Light based hair removal device 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, excluding patients with Fitzpatrick Skin Phototypes VI.
The Light Based Hair Removal Device 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 IPL technology. The device consists of IPL main body and adapter two parts, and a lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.
The provided document is a 510(k) Summary for a Light Based Hair Removal Device GP592. It discusses the device's substantial equivalence to a predicate device but does not include information about clinical studies with human participants to demonstrate specific acceptance criteria or device performance in terms of efficacy or safety. The document primarily focuses on nonclinical tests for safety and electromagnetic compatibility.
Therefore, requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it outlines nonclinical testing and substantial equivalence, not results from a human study demonstrating efficacy against acceptance criteria.
The document states:
- Nonclinical tests submitted:
- Safety test: IEC 60601-1: 2005+A1: 2012+A2:2020, IEC 60601-1-11: 2015
- EMC test: IEC 60601-1-2: 2020
- Reliability test: IEC 62471: 2006, IEC 60601-2-83: 2019
- Biocompatibility test: ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-23: 2021
- Conclusion: "None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests."
This indicates that the device met the requirements of these specific technical and safety standards, which serve as the "acceptance criteria" in this context. However, these are not performance metrics like sensitivity, specificity, or outcomes from a human clinical trial.
§ 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.