(122 days)
The IPL Hair Removal Device (Model: KCA423) indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. 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.
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This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (Model: KCA423). It primarily addresses the regulatory approval process and states the device's indications for use. It does not contain the detailed technical study information, acceptance criteria, or performance data that would be needed to answer your request fully.
The request asks for information typically found in a clinical study report or a 510(k) summary, which outlines the scientific evidence demonstrating the device meets performance criteria. This document only confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to a predicate device.
Therefore, I cannot provide the requested information based solely on the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the full 510(k) submission, specifically the sections detailing the performance data and clinical studies, which are not included in this FDA clearance letter.
§ 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.