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IPL Hair Removal Device is an over-the-counter device intended for 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 (Model: KCA511, KCA516,KCA522), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. 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 cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

IPL Hair Removal Device, model: KCA511, KCA516 and KCA522 have the same indication for use, performance, structure design and operation, the only deference is their appearance size and weight.

IPL Hair Removal is used for removing excess facial hair and body hair and can also reduce hair regrowth. The products can be used on body parts such as underarm, bikini line, arms, facial hair below the chin line, back and legs.

It is designed so that the flash window requires full contact with the skin to work (flash),it will no works as long as the flash window does not contact the skin.

This FDA 510(k) clearance letter and summary is for an IPL Hair Removal Device. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence. However, it does not contain the specific acceptance criteria or the study details proving the device meets those criteria, especially not in the format requested for AI/ML performance evaluations.

The document focuses on:

• Regulatory Classification: Class II, OHT product code, 21 CFR 878.4810 (Laser surgical instrument for use in general and plastic surgery and in dermatology).
• Intended Use: Removal of unwanted hair and permanent reduction in hair regrowth (measured at 6, 9, and 12 months post-treatment).
• Technological Comparison: Comparing the subject device (IPL Hair Removal Device, KCA511/KCA516/KCA522) to a predicate device (K240282) and a reference device (K230122) in terms of intended use, design, specifications, and performance.
• Performance Data: This section only covers non-clinical testing for:
  • Biocompatibility: Tests conducted according to ISO 10993 series (cytotoxicity, irritation, skin sensitization).
  • Electrical Safety and EMC: Compliance with various IEC 60601 standards.
  • Eye Safety: Compliance with IEC 62471.
  • Software Verification and Validation: Stating that software requirements were met and hazards mitigated.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML evaluation).
2. Sample size, data provenance, number of experts, qualifications, or adjudication methods for a test set. This type of information is typically associated with clinical studies or performance evaluations where a "ground truth" is established, which is entirely absent here.
3. Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or the effect size of human readers with/without AI assistance. This is relevant for AI-assisted diagnostic or decision-making devices, not a direct energy hair removal device.
4. Whether a standalone (algorithm only) performance was done. Again, pertaining to AI/ML devices.
5. The type of ground truth used (expert consensus, pathology, outcomes data, etc.). This is not applicable given the type of device and the information provided.
6. The sample size for the training set or how its ground truth was established. This refers to AI/ML model development, which is not described.

In summary, the provided FDA 510(k) clearance letter and summary pertains to a physical IPL hair removal device, not a software or AI/ML-driven diagnostic or decision-support system. As such, the requested details regarding acceptance criteria, study methodologies, and ground truth establishment, which are typical for AI/ML performance evaluation, are not present in this document.

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IPL Hair Removal Device is an over-the-counter device intended for 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.

Not Found

The provided FDA document is a 510(k) clearance letter for an IPL Hair Removal Device. It indicates that the device is substantially equivalent to legally marketed predicate devices.

This document DOES NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in an AI/ML medical device submission.

510(k) clearances for devices like this IPL hair removal device primarily focus on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics and the information submitted demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This often involves performance testing to ensure safety and effectiveness are comparable, but not necessarily adherence to predefined, numerical acceptance criteria for AI/ML performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information relating to AI/ML device performance from the provided text for the following reasons:

• The device is an IPL Hair Removal Device, not an AI/ML-driven diagnostic or treatment device. The 510(k) addresses an Intensed Pulsed Light device, which is a physical apparatus, not a software algorithm.
• The document is a clearance letter, not a detailed study report or clinical trial summary. Clinical trial data or detailed performance studies (especially relating to AI algorithms) are typically far more extensive than what is summarized in the 510(k) clearance letter itself. Such detailed information would generally be found in the full 510(k) submission, which is not provided here.
• There is no mention of an AI algorithm, machine learning, or software-based analysis of medical images/data. The "Indications for Use" describe mechanical hair removal and reduction, not diagnostic tasks that would typically employ AI.

If you have a document pertaining to an AI/ML medical device, please provide that, and I would be happy to analyze it for the requested information.

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