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

The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.

IPL Home Use Hair Removal Device includes D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.

This is an FDA 510(k) summary for an IPL Home Use Hair Removal Device. The document establishes substantial equivalence to a predicate device, which is the primary mechanism for FDA clearance of Class II devices like this.

Based on the provided text, a formal study proving the device meets specific acceptance criteria for a new AI/algorithm-driven medical device, as typically described in an acceptance criteria table, was not conducted or reported in this 510(k) summary.

This 510(k) focuses on demonstrating that the IPL Home Use Hair Removal Device is substantially equivalent to legally marketed predicate devices, not on proving new clinical performance through a comparative effectiveness study involving AI or human readers. The "Performance Data" section primarily addresses safety (biocompatibility, electrical safety, EMC, eye safety, software V&V) rather than clinical efficacy through human subject testing.

Therefore, many of the specific details requested in the prompt, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" related to an AI/algorithm, are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance (Not Applicable in the context of AI/Algorithm Performance)

Since this is an IPL hair removal device and not an AI/algorithm-driven diagnostic or assistive device in the typical sense for which such a table would be generated, there are no specific AI model performance acceptance criteria or reported metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are implicitly meeting the safety and performance standards demonstrated by the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (As applicable from the 510(k) Summary):

1. Sample sizes used for the test set and the data provenance:

   • Test Set: No specific "test set" in the context of an algorithmic performance study for an AI device. The testing outlined (biocompatibility, electrical safety, etc.) is laboratory-based and engineering verification/validation, not a clinical trial with a "test set" of patient data for an algorithm. Clinical performance is demonstrated by the substantial equivalence to the predicate device, which implicitly means its performance for hair removal is considered equivalent without a new clinical study.
   • Data Provenance: Not specified for any performance testing, but the company is Shenzhen Beauty Every Moment intelligent electric Co., Ltd. (China). This suggests testing was likely conducted in China or by labs utilized by the manufacturer. The document doesn't mention retrospective or prospective human data collection for efficacy.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There is no mention of an expert-adjudicated ground truth for an AI algorithm in this 510(k) summary.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No such clinical "test set" or adjudication method for an algorithm is described.

4. 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:

   • No. An MRMC comparative effectiveness study was not conducted or reported here. This is an IPL hair removal device, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for an AI algorithm. For the function of the device itself, the "ground truth" for "hair removal" would typically be visual assessment of hair reduction, but no such clinical study specific to this submission is detailed. The performance relies on substantial equivalence to the predicate.

7. The sample size for the training set:

   • Not applicable. There is no AI algorithm being trained mentioned in this submission.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI algorithm being trained mentioned in this submission.

In summary: This 510(k) clearance document for an IPL Home Use Hair Removal Device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that its safety and performance (including efficacy for hair removal) are considered equivalent based on engineering design, specifications, and device characteristic comparisons, supplemented by standard safety testing (biocompatibility, electrical safety, eye safety, software V&V). It does not involve the type of clinical performance study required for novel AI/algorithm-driven diagnostic or therapeutic devices that directly assist or interpret medical data for human users or make decisions.

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

The IPL Home Use 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1198, D-1186, D-1189, D-1197 five models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains PCB layout, product appearance and internal construction, but these differences do not affect or change the intended use of the device.

This document is a 510(k) Pre-market Notification for an IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics for the subject device's clinical effectiveness.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for proving clinical effectiveness cannot be fully provided from the given text. This document primarily addresses safety and technical aspects through comparisons and compliance with standards.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: No specific numerical acceptance criteria for clinical effectiveness (e.g., percentage hair reduction, safety endpoints with thresholds) are explicitly stated for the subject device in this document. The document refers to "similar safety and effectiveness profile" and "performance data supports that the device is safe and as effective."
• Reported Device Performance:
  • Clinical Effectiveness: The document states the device "works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain." However, no quantitative data on hair reduction percentage, pain scores, or other effectiveness metrics are provided for the subject device. The safety is "similar to the predicate device."
  • Technical Performance (derived from comparison table in Section VI):
    • Wavelength range: 550-1100nm
    • Energy medium: Xenon Arc Flashlamp
    • Energy density: 2.0-4.3 J/cm²
    • Spot size: D-1198: 2.7cm², D-1185: 2.7cm², D-1186: 3.0cm², D-1189: 3.0cm², D-1197: 3.4cm²
    • Pulse duration: 5-12ms
    • Pulsing control: Finger switch
    • Delivery device: Direct illumination to tissue
  • Safety Performance (as per Section VII - Performance Data):
    • Biocompatibility: Materials are identical to the predicate device (K211185), thus deemed safe.
    • Electrical Safety & Eye Safety: Passed IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 standards.
    • Software Verification and Validation: Passed, meeting all software requirement specifications and mitigating hazards to acceptable risk levels.

2. Sample size used for the test set and the data provenance:

• Not provided. This document does not describe a clinical test set with specific sample sizes for evaluating hair reduction or other clinical efficacy outcomes. The safety and effectiveness claims are based on comparison to a predicate device and compliance with technical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. Since no specific clinical test set for efficacy is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. No clinical test set involving human judgment and adjudication is described.

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 IPL hair removal device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

• Not applicable in the context of clinical efficacy. While the device itself operates standalone for hair removal, the performance data presented primarily pertains to safety (electrical, eye, biocompatibility) and technical specifications, not a clinical "algorithm only" performance for diagnosis/treatment in the typical sense of AI devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not provided for clinical efficacy. For safety, the "ground truth" is established by compliance with international standards (IEC standards) and prior FDA clearance of similar materials (for biocompatibility).

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" in the context of an IPL hair removal device's clinical efficacy or safety. The device does contain software, and "Software Verification and Validation" was performed, but details about a "training set" for software development are not included.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. As with point 8, no training set for clinical efficacy is mentioned.

Summary of what is present:

This 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed predicate device (Bosidin IPL Home Use Hair Removal Device/D-1171, K211185). The key arguments for equivalence are:

• Identical Indications for Use: "removal of unwanted body and/or facial hair." (Section V, VI)
• Similar Mode of Action and Operational Characteristics: Uses Intense Pulsed Light (IPL) technology. (Section VI)
• Comparable Technical Specifications: Wavelength range, energy medium, energy density, spot size, pulse duration, pulsing control, delivery method are similar or within acceptable ranges. (Section VI table)
• Safety Compliance: The device components are biocompatible (identical to predicate materials), and it has passed multiple electrical and eye safety standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 62471). Software has also undergone verification and validation. (Section VII)

The document concludes that "the IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device" and is "substantially equivalent." This type of submission usually implies that extensive new clinical efficacy trials for the subject device were not deemed necessary by the FDA because of the strong similarity to an already cleared device.

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

The IPL Home Use 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents and the number of button, lamp cartridge's quantity and appearance; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.

This document is a 510(k) Summary for an IPL Home Use Hair Removal Device. It describes the device, compares it to predicate devices, and outlines the performance data submitted to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests related to safety and general functionality.

However, we can infer the "acceptance criteria" for the tests performed as passing the relevant safety standards.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a clinical test set for hair removal efficacy. The performance data presented focuses on non-clinical testing (biocompatibility, electrical safety, eye safety, software verification).

• Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of units tested for electrical safety).
• Data Provenance: The document is a 510(k) submission, typically containing test reports from the manufacturer. The location of the manufacturer is Shenzhen, Guangdong, China. The document does not indicate whether the data is retrospective or prospective for any clinical studies, as no clinical studies with human subjects are detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable or provided in the document as it focuses on non-clinical engineering and safety aspects, not a clinical study requiring expert assessment of outcomes like hair reduction or disease diagnosis. There is no mention of ground truth establishment by experts for the performance data presented.

4. Adjudication method for the test set

This information is not applicable or provided as there is no human-centric clinical test set requiring adjudication.

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

This information is not applicable. The device is an IPL hair removal device for direct consumer use, not an AI-assisted diagnostic imaging tool that would involve human readers (e.g., radiologists). There is no mention of an MRMC study or AI assistance for human readers.

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

This information is not applicable. The device is a physical IPL hair removal device, not an algorithm. Its operation involves a user directly applying it.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data (biocompatibility, electrical safety, eye safety, software V&V), the "ground truth" is defined by established international and national standards (e.g., ISO 10993, IEC 60601, IEC 62471). The device is tested against these predefined safety and performance criteria.

8. The sample size for the training set

This information is not applicable. As a physical IPL device without an AI component that learns from data, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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

The IPL Home Use 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. 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 is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1129, D-1130, D-1119, D-1119, D-1103, D-1176, D-1151, D-T1002 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents, lamp cartridge's quantity and appearance as well as the placement location of lamp tube; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.

The provided document describes an FDA 510(k) summary for an IPL Home Use Hair Removal Device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to efficacy (hair removal performance) using human subjects or an AI component.

Instead, the performance data discussed focuses on the following:

• Biocompatibility Testing: Ensuring the materials in contact with the body are safe.
• Electrical Safety and Eye Safety: Adherence to electrical safety standards and photobiological safety standards.
• Software Verification and Validation: For the device's moderate level of concern software.

The document states: "Based on the above performance as documented in this application, the subject device IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device." This "effectiveness profile" is likely inferred from the similarity in technological characteristics (like wavelength range, energy density, spot size, pulse duration) to the predicate device, which presumably demonstrated effectiveness in its clearance.

Therefore, I cannot provide the requested table and study details as the document does not present a standalone clinical study with acceptance criteria for hair removal efficacy or an AI component that meets those criteria. The provided information is limited to safety and technical similarity to a predicate device.

If the request was based on a misunderstanding of what information is present in the document, and it's seeking a general outline of what such a response would look like for a hypothetical device with AI and clinical performance data, please let me know.

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