(157 days)
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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.
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It has skin-safe detection. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
The provided text is an FDA 510(k) clearance letter for an "Ice Cooling IPL Hair Removal Device." It describes the device, its intended use, and a comparison with predicate devices to establish substantial equivalence. However, this document does not contain, nor is it expected to contain, the detailed acceptance criteria and study results typically found in a clinical study report for device performance, especially for AI/ML-driven devices involving expert interpretation or comparative effectiveness studies.
The document focuses on:
- Substantial Equivalence: Demonstrating the new device is as safe and effective as legally marketed predicate devices.
- Performance Data (Non-Clinical): Summarizing tests for biocompatibility, electrical safety and EMC, eye safety, software verification and validation, and usability. These are largely engineering and safety tests rather than evaluations of device clinical effectiveness (e.g., hair removal efficacy).
Therefore, I cannot fulfill your request for acceptance criteria and study details related to "device performance" in the context of an AI/ML device (e.g., human reader improvement with AI assistance, standalone algorithm performance, ground truth establishment by experts, MRMC studies) because this information is not present in the provided FDA clearance letter.
The device described is an IPL (Intense Pulsed Light) hair removal device, which is a physical device that emits light to reduce hair growth. It does have software/firmware control, but it's not presented as an AI/ML-driven diagnostic or imaging interpretation device that would involve the kind of "acceptance criteria" you've outlined (e.g., related to sensitivity, specificity, or expert consensus on interpretations). The "performance data" here relates to the safety and fundamental operation of the physical device as required for a 510(k) submission.
§ 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.