(190 days)
IPL 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 Hair Removal Device (Models:YT01, YT02, YT04) 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 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. 550 filter is applied in models YT01&YT02, 600 filter is applied in model YT03 and 640 filter is applied in model YT04.
The provided FDA 510(k) summary for the IPL Hair Removal Device (K240016) indicates that no clinical data was submitted, and therefore, no study was conducted to prove the device meets specific acceptance criteria based on human performance or AI/algorithm performance. The clearance for this device is based on its substantial equivalence to predicate devices, supported by non-clinical testing.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is typically only available when clinical studies or performance testing are performed and submitted, which was not the case for this 510(k) submission as explicitly stated in the document: "Not applicable. There's no clinical data for the subject device."
The non-clinical tests summarized are:
- Verification of output energy density
- Pulse duration time
- Valid times of flashes
- Human factors engineering verification (to ensure laypersons can choose and use the device)
- Luminous transmittance of goggles (to ensure eye safety)
These tests are typically performed against engineering specifications and industry standards (e.g., IEC 60601-2-83 and IEC 62471), not against user performance metrics or AI/algorithm performance.
In summary, none of the requested information (acceptance criteria for clinical performance, study details, sample sizes, expert involvement, etc.) can be extracted from the provided text because no clinical data or comparative performance study was conducted or submitted for this specific device clearance.
§ 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.