(198 days)
The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction. In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions. The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.
Not Found
I am sorry, but the provided text is a 510(k) summary letter from the FDA, and it does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The letter primarily confirms that the FDA has reviewed Cyden Limited's iPulse System and found it substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
It details the device name, regulation number, regulatory class, and indications for use. However, it does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes, data provenance, or expert qualifications for studies.
- Details on adjudication methods, MRMC studies, or standalone algorithm performance.
- Information on the type of ground truth used or details about training sets.
To get the information you are looking for, you would need to consult a different document, such as the full 510(k) submission, clinical study reports, or performance data provided by the manufacturer.
§ 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.