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Light Based Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The Light Based Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse.

There are A113, A112, and AM001 three models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size, and energy output density are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

The provided document is a 510(k) summary for a Light Based Hair Removal Device. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain the results of a study that establishes acceptance criteria for device performance based on clinical efficacy or specific hair removal results in humans.

This 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device through:

• Technological Characteristics Comparison: Showing that the subject device has similar design, wavelength range, energy medium, energy density (within comparable ranges), spot size, pulse duration, pulsing control, and delivery method as the predicate devices.
• Performance Data (Safety Standards): Showing that the device meets various safety standards, including biocompatibility, electrical safety, electromagnetic compatibility (EMC), eye safety, and software verification/validation.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance (in terms of clinical efficacy for hair removal).
2. Sample size used for the test set and data provenance related to clinical efficacy.
3. Number of experts used to establish ground truth for clinical efficacy.
4. Adjudication method for a clinical test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance related to clinical efficacy.
7. Type of ground truth used for clinical efficacy (e.g., pathology, outcomes data).
8. Sample size for the training set (related to clinical efficacy).
9. How the ground truth for the training set was established (related to clinical efficacy).

The document's "Performance Data" section solely addresses various safety and engineering standards, not clinical efficacy acceptance criteria for hair removal. The "acceptance criteria" discussed in the document are about compliance with these technical safety standards.

Based on the provided document, here is what can be extracted regarding the device performance in terms of safety and engineering standards:

1. Table of Acceptance Criteria and Reported Device Performance (Focus on Safety Standards):

Notes on what cannot be provided from this document:

• This document does not describe a clinical study to prove the device meets acceptance criteria for hair removal efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to various safety and engineering standards.
• There is no mention of sample sizes for clinical efficacy studies, data provenance for such studies, expert involvement in establishing clinical ground truth, or adjudication methods for clinical outcomes.
• No MRMC comparative effectiveness study or standalone algorithm performance for hair removal efficacy is reported.
• The "ground truth" used in this document refers to the established standards for safety, biocompatibility, electrical performance, and software quality, not clinical outcomes related to hair removal.
• The document does not provide details on a training set or how ground truth was established for a training set, as it does not describe an AI/ML-driven device that learns from data in that context. The software validation mentioned is for the device's operational software, not for an AI component for clinical assessment.

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Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.

The provided document is a 510(k) Summary for a Light Based Hair Removal Device GP592. It discusses the device's substantial equivalence to a predicate device but does not include information about clinical studies with human participants to demonstrate specific acceptance criteria or device performance in terms of efficacy or safety. The document primarily focuses on nonclinical tests for safety and electromagnetic compatibility.

Therefore, requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it outlines nonclinical testing and substantial equivalence, not results from a human study demonstrating efficacy against acceptance criteria.

The document states:

• Nonclinical tests submitted:
  • Safety test: IEC 60601-1: 2005+A1: 2012+A2:2020, IEC 60601-1-11: 2015
  • EMC test: IEC 60601-1-2: 2020
  • Reliability test: IEC 62471: 2006, IEC 60601-2-83: 2019
  • Biocompatibility test: ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-23: 2021
• Conclusion: "None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests."

This indicates that the device met the requirements of these specific technical and safety standards, which serve as the "acceptance criteria" in this context. However, these are not performance metrics like sensitivity, specificity, or outcomes from a human clinical trial.

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Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

The Light based hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.

This document, K180383, is a 510(k) summary for the "Light based hair removal device" by Shenzhen GSD Tech Co., Ltd. It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA approval.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for efficacy or hair reduction. The core of the submission is to demonstrate that the new device is as safe and effective as previously cleared devices.

The "acceptance criteria" in this context are interpreted as compliance with relevant regulatory standards and demonstrating similar technological and performance characteristics to the predicate device, implying similar safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and not a study with specific efficacy endpoints, there isn't a direct "acceptance criteria" table in terms of clinical performance metrics (e.g., % hair reduction). Instead, the performance shown is in relation to safety and regulatory compliance.

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

• No human clinical study data is presented for efficacy. The studies described are engineering/laboratory tests (biocompatibility, electrical safety, eye safety, software validation).
• Therefore, there is no "test set" in the context of human subjects, nor data provenance (country of origin, retrospective/prospective).

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

• Not applicable. As no human clinical efficacy study is described, there is no "ground truth" established by experts in that context. The "ground truth" for the engineering tests would be the established international standards themselves, and the expertise lies with the testing laboratories performing the assessments.

4. Adjudication Method for the Test Set

• Not applicable. There is no human clinical test set requiring adjudication in the document.

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 a light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was done or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithmic device in the sense of AI. The software validation is for the device's operational software, not for an AI algorithm.

7. The Type of Ground Truth Used

• For the engineering tests, the "ground truth" is the established and recognized international standards (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). Compliance with these standards indicates safety and performance.

8. The Sample Size for the Training Set

• Not applicable. There is no machine learning or AI component mentioned that would require a "training set."

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary:

This 510(k) submission demonstrates the substantial equivalence of the "Light based hair removal device" by showing that it meets recognized safety and performance standards through engineering and biocompatibility testing, and that its technological characteristics are similar to those of predicate devices. It does not include clinical efficacy studies with human subjects or AI performance evaluations.

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