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The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the reduction of hair growth based on 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 powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission.

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin color sensor is fixed in "Skin color recognition Window" of IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. The capacitive sensor is assembled in the device probe of IPL Hair Removal device, if the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Based on the cooling technology, IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

The IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S can be powered on built-in battery or cable adaptor. The built-in lithium battery can be recharged. When the capacity of battery is low, the battery icon " " " display red on the screen. When the When battery icon " t = " display red with blinking for about 20s the device will turn off. The recharge time of the battery is about 3 hours and when full charged and turn on level 5 to treatment the using time about 45 mins.

When the device is turned on under battery-powered and insert the adaptor with the device, the device will be shut down and to charge. If you want to treatment, you shall turn on the device again with the cable adaptor.

When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again.

The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver.

The device is intended to be used for adults aged over 18.

Principle of operation:

Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.

This document is a 510(k) Premarket Notification summary for an IPL Hair Removal device. It largely focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing and comparison of technical specifications, rather than clinical performance data. Therefore, the information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/human reader performance, is largely absent.

Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:

Acceptance Criteria and Device Performance:

• Table of acceptance criteria and reported device performance: This document does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in hair growth percentage) that an "AI device" would typically have. The acceptance is based on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards.

Study Proving Device Meets Acceptance Criteria:

• 1. A table of acceptance criteria and the reported device performance: As noted above, specific performance-based acceptance criteria for hair removal efficacy are not detailed in this 510(k) summary. The acceptance is based on meeting safety standards and having comparable technical characteristics to predicate devices.
• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document explicitly states: "There was no clinical testing performed." (Page 10, Section 8). This means there is no test set in the sense of a clinical study with patients. The "test set" here refers to non-clinical tests (electrical safety, EMC, biocompatibility, etc.) against recognized standards. Data provenance is not applicable for these non-clinical tests in the way it would be for clinical data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): This is not applicable as no clinical testing was performed and therefore no "ground truth" established by experts for performance evaluation.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable due to the absence of clinical testing.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an Intense Pulsed Light (IPL) hair removal device, not an AI diagnostic or assistance system for human readers. It functions autonomously for hair removal.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's operation is "standalone" in the sense that it doesn't involve an AI algorithm interpreting medical images for a human. It's a direct-use consumer device. Its performance is assessed through its physical characteristics and safety features, not through an algorithm's diagnostic output.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests performed, the "ground truth" is adherence to established engineering and safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-5 for cytotoxicity). There's no biological or diagnostic "ground truth" in the typical sense.
• 8. The sample size for the training set: Not applicable. This is a physical device, and the summary does not mention any AI/machine learning components that would require a training set for an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Approval Basis:

The IPL Hair Removal device (models Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over-The-Counter device intended for the removal of unwanted body hair. It uses Intense Pulsed Light (IPL) technology to disable hair follicles.

The FDA's decision of "substantial equivalence" is based on:

• Comparison to Predicate Devices: The applicant demonstrates that the subject device has similar technological characteristics (e.g., principle of operation, light source, patient population, environment of use) and indications for use to legally marketed predicate devices (K183217, K223928).
• Non-Clinical Testing: The device was tested for safety and effectiveness against a series of recognized consensus standards, including:
  • ANSI AAMI ES60601-1 (General safety and essential performance of medical electrical equipment)
  • IEC 60601-1-2 (Electromagnetic compatibility)
  • ANSI/AAMI HA60601-1-11 (Medical electrical equipment for home healthcare environment)
  • IEC 60601-2-83 (Particular requirements for home light therapy equipment)
  • IEC 62471 (Photobiological safety)
  • ISO 10993-5 (Biocompatibility - in vitro cytotoxicity)
  • ISO 10993-10 (Biocompatibility - irritation and skin sensitization)
  • IEC 62133-2 (Safety requirements for lithium batteries)
  • IEC 62304 (Medical device software life cycle processes)
• No Clinical Testing: The document explicitly states that no clinical testing was performed to support the substantial equivalence claim. The assumption is that if the technical specifications and safety features are similar to predicate devices that were previously cleared, and the device meets relevant safety standards, then it is substantially equivalent in terms of safety and effectiveness.

In essence, this FDA 510(k) summary is for a physical medical device, not an AI/ML powered diagnostic or assistance tool. Therefore, the criteria and study methodology you've outlined, which are typical for AI-enabled medical devices, do not apply here.

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