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Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

Hair Removal Device (Model: R3C16-P, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction 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. Hair Removal Device includes two series (R3C16 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with "Pro" in the model name is equipped with sapphire while the model without "Pro" uses metal treatment window surface.

This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results for the Hair Removal Device. However, based on the provided text, here's an analysis of what can be extracted.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it relies on a comparison to predicate devices and adherence to various safety and performance standards.

We can infer the intent of some acceptance criteria by looking at the "Comparison Elements" table on pages 7-8 and the "Non-Clinical Testing" section on page 9. The underlying acceptance is that the subject device's characteristics and performance are "similar" or "same" to the predicate devices and meet the specified international standards for medical electrical equipment and photobiological safety.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "VIII. Clinical Testing: Not applicable."
This means there was no clinical test set for evaluating the device's hair removal efficacy and safety on human subjects as part of this 510(k) submission. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not provided for efficacy testing.

The "non-clinical testing" mentioned primarily refers to bench testing and adherence to international safety and performance standards for medical devices and photobiological safety. For these tests, specific sample sizes (e.g., number of devices tested for electrical safety, materials tested for biocompatibility) are typically defined by the respective standards, but these details are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical testing was applicable or performed for this 510(k) submission, there was no clinical test set for which ground truth needed to be established by experts for efficacy. The evaluation was based on non-clinical characteristic comparisons and technical standard compliance.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication for ground truth was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Done

No. The document explicitly states "VIII. Clinical Testing: Not applicable." An MRMC study would be a type of clinical comparative effectiveness study, which was not done.

6. Standalone Performance Done

The performance evaluation in this 510(k) is primarily a standalone assessment of the device's technical specifications and compliance with safety standards. The comparison to predicates is to demonstrate "substantial equivalence" based on similar characteristics and the device meeting the same technical and safety requirements. The non-clinical tests (e.g., biocompatibility, electrical safety, photobiological safety) are assessments of the device itself (standalone).

7. Type of Ground Truth Used

Given the "Clinical Testing: Not applicable" statement, there was no clinical "ground truth" related to hair removal efficacy established or used in this submission. The "ground truth" for the non-clinical tests would be the requirements and limits defined by the referenced international standards (e.g., IEC, ISO standards). For example, the ground truth for cytotoxicity testing is whether the material shows cytotoxic effects according to the criteria in ISO 10993-5.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware product for hair removal, not an AI/ML algorithm that requires a training set in the typical sense. The "software/firmware/microprocessor control" mentioned refers to embedded control systems for device operation (e.g., intensity levels, safety features), not for learning or diagnostic purposes that would require a large training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of an AI/ML algorithm training set.

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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 (PL). It is designed with clual lamps that work together and can emit single, continuously double or triple pulses per shot. It works below the sky cutting or pulling, reducing hair growth with nearly pain. It has three modes: Fast Mode, Normal Mode and High Mode. The device is only powered by the external pover adapter and its by finger switch. This product adopts sapplive treatment window that is suitable for multiple hair removal areas. It has 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 plas the ice cooling finction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text describes the regulatory filing for the "Ice Cooling IPL Hair Removal Device" and includes a comparison to predicate devices, but it does not contain information about a specific study proving the device meets acceptance criteria in the manner requested (e.g., clinical trial with performance metrics like sensitivity, specificity, accuracy, or effectiveness of AI assistance to human readers).

The document details:

• Indications for Use: Removal of unwanted hair and permanent reduction in hair regrowth (defined as reduction at 6, 9, and 12 months post-treatment regime).
• Comparison to Predicate Devices: A table comparing characteristics like regulation number, product code, light source, wavelength range, energy density, and pulse duration.
• Performance Data (Summary of performance testing): This section outlines bench testing and compliance with various international standards related to biocompatibility, electrical safety and EMC, light safety, software verification/validation, and usability. It does not include clinical efficacy data or performance metrics directly addressing the "permanent reduction in hair regrowth" claim.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance related to a clinical outcome.
2. Sample size for a clinical test set or its provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a clinical test set.
5. MRMC study effect size.
6. Standalone performance.
7. Type of ground truth used for clinical effectiveness.
8. Sample size for a clinical training set.
9. How ground truth for a clinical training set was established.

The performance data summarized focuses on safety, electrical compliance, usability, and software testing, rather than a clinical study evaluating the device's hair removal efficacy against specific performance targets. The "conclusion" states the device "is as safe, as effective, and performs as well as the legally marketed predicate device," which is a statement of substantial equivalence based on the engineering and safety tests, and similarity to predicate devices, not on a new clinical effectiveness study presented in this summary.

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The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold 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.

The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) system consisting of:

Handset - contained within the handset is the Capacitor, Capacitor Charger, Control electronics, Optics (Lamp, Filter, Reflector, Light Pipe), Trigger mechanism and Skin Tone / proximity Sensors (STS);

External Power Supply - used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a lower DC value, typically 24V. This power supply unit is an "off-the-shelf" component which meets all the relevant electrical safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 50 subjects for the 6-month post-treatment evaluation, and 33 subjects for the 12-month post-treatment evaluation.
• Data Provenance: Prospective, single-center clinical study. The country of origin of the data is not explicitly stated, but the company (iPulse Limited) is based in Swansea, Wales, United Kingdom.

3. Number of Experts and Qualifications for Ground Truth:

• The ground truth for hair count was established by 2 independent assessors.
• Their specific qualifications (e.g., radiologist with X years of experience) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set:

• The results from the 2 independent assessors were averaged. This implies a form of consensus or averaging method rather than a strict 2+1 or 3+1 adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on device performance for hair reduction, not on human reader improvement with or without AI assistance.

6. Standalone Performance:

• Yes, a standalone performance study was done. The clinical testing assessed the iPulse SmoothSkin Gold Hair Removal System directly for its efficacy in hair reduction without human-in-the-loop performance in terms of interpretation or decision-making. The device is an over-the-counter hair removal system.

7. Type of Ground Truth Used:

• Expert consensus (averaged hair counts) based on direct physiological measurements (hair counts) and clinical photographs.

8. Sample Size for the Training Set:

• The provided text does not explicitly mention a separate "training set" or its sample size. The clinical study described appears to be the primary efficacy evaluation without a distinct training phase in the context of an AI/algorithm.

9. How Ground Truth for the Training Set Was Established:

• Not applicable, as a separate training set is not explicitly described for an AI/algorithm. The ground truth for the clinical efficacy evaluation (the device's performance) was established by the averaged hair counts from 2 independent assessors.

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