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

IPL Hair Removal Device includes two models, IPL-001 and IPL-002. The two models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters.

The device is only powered by the external power adapter. This device adopts light exit window (the IPL-002 adopts sapphire light exit window) that is suitable for multiple hair removal areas. The device is fitted with a skin sensor to detect appropriate skin contact, if the light exit window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. Model IPL-002 has a cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

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IPL Hair Removal Device is an over-the counter device intended for removal of unwanted body hair. The device is used for adults with Fitzpatrick skin types I-IV.

IPL Hair Removal Device is a small over-the-counter device for the permanent 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 IPL Hair Removal Device includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a finger switch or auto light emission. If the light outlet of the device is not fully contact with the skin, the device cannot emit the treatment light pulses. The device includes MLY-M011,MLY-M012,MLY-M013,MLY-M015,MLY-T001,MLY-T002 six models. There is difference in product appearance, cooling function, physical product dimension, indicator display and spot size, but their intended use, performance,output energy, structure design and operation are basically identical. MLY-M011 has no cooling function,while other models(MLY-M012,MLY-M013,MLY-M015,MLY-T001,MLY-T002) have cooling function.

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

The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The IPL 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 technology(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).

The Intense Pulsed Light technology 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. The device contains a Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.

In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.

The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.

The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.

The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.

Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.

Specifically, the following information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
2. Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
3. Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
4. Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
5. MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
6. Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
7. Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
8. Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 16) only lists compliance with:

• Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
• Electrical Safety and EMC Safety: IEC 60601 series standards.
• Eye Safety: IEC 62471 standard.
• Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."

These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.

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

The IPL 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 IPL 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 HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance，size，and operation are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L). The request asks to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance beyond basic safety and electrical testing.

However, the provided 510(k) clearance letter and summary primarily focus on establishing substantial equivalence to predicate devices through comparisons of technical specifications and robust safety testing (biocompatibility, electrical safety, eye safety, and software verification).

There is no detailed information provided in this document regarding a clinical performance study (e.g., patient trials, or studies that measure the actual effectiveness of hair removal) beyond the statement that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." The "Performance Data" section specifically lists only safety and software V&V, not clinical efficacy.

Therefore, I cannot fully complete all sections of your request as the provided text does not contain the specific clinical performance study details you are asking for. The clearance is based on the device being "substantially equivalent" to predicate devices that are already cleared for the specified indications for use, and a demonstration that the new device meets relevant safety standards and its software functions as intended.

Here's what can be extracted and inferred based on the provided document:

Acceptance Criteria and Device Performance (Based on Provided Document)

While the document doesn't detail specific clinical efficacy acceptance criteria for the hair removal function, it does outline acceptance criteria for safety and technical performance, which are crucial for FDA clearance. The "study" proving these are met refers to the various engineering and safety tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Performance Test Set: Not applicable / Not specified in this document for a clinical efficacy study. The document focuses on bench testing and safety compliance.
• Safety Testing (Biocompatibility, Electrical, Eye): The "sample size" for these tests would typically refer to the number of devices or material samples tested. This information is not detailed in the provided 510(k) summary (e.g., how many units underwent electrical safety testing).
• Data Provenance: Implied to be from the manufacturer's own testing conducted in China (where the manufacturer is located). The nature of these tests (e.g., bench testing) makes the "retrospective or prospective" classification less applicable than for clinical data.

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

• Not applicable for this type of submission. This 510(k) relies on standardized engineering and safety tests, and establishing "ground truth" for these types of tests is typically based on adherence to the specified international standards (e.g., IEC, ISO) and laboratory procedures, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

• Not applicable for this type of submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert readers or evaluators independently assess data (e.g., medical images). The tests described here are compliance tests against predefined standards.

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

• No. An MRMC study is a specific type of clinical study used primarily for medical imaging devices to evaluate human reader performance with and without an AI algorithm. This document describes a physical hair removal device, not an imaging device, and does not mention any clinical comparative effectiveness study, especially not one involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable for this type of device. This device is a direct-use consumer product. While it has "Software Verification and Validation," this refers to the embedded software controlling the device's functions (e.g., light emission, skin sensor), not a standalone diagnostic algorithm whose performance would be measured independently.

7. The Type of Ground Truth Used

• For safety and electrical performance: Ground truth is established by the requirements and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device's performance is measured against the specifications and limits defined by these standards.
• For substantial equivalence: The ground truth is the performance and safety data of the legally marketed predicate devices, against which the subject device is compared. The argument is that the subject device's technical characteristics and tested safety performance are "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

• Not applicable. This document describes the clearance of a physical medical device, not a machine learning or AI model that requires a "training set" of data. The software verification mentioned refers to traditional software testing methodologies.

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

• Not applicable. (See point 8).

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IPL Hair Removal Device 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.

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed twenty-three models with the same IPL technology for hair removal, which is model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL20, BHRL-21, BHRL-22. The device 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.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6±0.25cm² (Model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL09, BHRL-10) and 2.7±0.25cm² (Model BHRL-05, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-06, BHRL-06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22) that is suitable for multiple hair removal areas, such as large areas (e.g. face, arms, legs) and small areas (e.g. armpits, bikini line).

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function (except model: BHRL-06B), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided FDA 510(k) Clearance Letter concerns an IPL Hair Removal Device. It is clear from the document that this device is a physical product (Intense Pulsed Light device) designed for hair removal, not an AI/software-based medical device that would involve a test set for ground truth establishment, expert readers, or MRMC studies.

Therefore, the request to describe acceptance criteria and a study proving the device meets those criteria, focusing on aspects like AI performance, sample size for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training/test sets, is not applicable to this device clearance.

The performance data provided in the 510(k) summary for this IPL Hair Removal Device focuses on:

• Biocompatibility Evaluation: Ensuring the materials are safe for body contact.
• Electrical Safety and EMC: Compliance with international safety and electromagnetic compatibility standards (IEC 60601 series).
• Eye Safety: Compliance with photobiological safety standards (IEC 62471).
• Software Verification and Validation: This refers to the embedded software controlling the device's hardware functions, not an AI algorithm performing diagnostic or therapeutic analysis based on data inputs. The documentation level of concern is "basic."
• Usability: Evaluation according to FDA guidance for human factors.

These are standard testing requirements for physical medical devices and do not involve the types of studies or acceptance criteria that would be relevant for an AI-powered diagnostic or therapeutic algorithm.

Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation based on the provided document. The document describes a traditional hardware-based medical device clearance.

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

IPL Hair Removal Device is an over-the-counter, light based device for unwanted hair removal by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any culling, removing hair growth with minimal pain.

The device includes three models with the only difference in enclosure color. It is only power adapter and its PL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a sapplire cooling function for a better hair removal experience.

This document is a 510(k) premarket notification for an IPL Hair Removal Device (BE965A, BE965B, BE965C). It states that non-clinical testing was conducted to verify that the device meets all design specifications and is substantially equivalent to predicate devices. However, the document explicitly says:

"The clinical test is not applicable, there's no clinical data."

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets clinical acceptance criteria, as no clinical study was performed or cited in this document.

The document focuses on demonstrating substantial equivalence through non-clinical testing against a set of established electrical, safety, and biocompatibility standards. It does not contain information on device performance in terms of hair removal efficacy or safety as evaluated in a clinical setting with human subjects.

As a result, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies for clinical performance.

The document instead lists various international standards that the device complies with, which relate to electrical safety, electromagnetic compatibility, home healthcare environments, home light therapy equipment, photobiological safety, usability, and biocompatibility.

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

IPL Hair Removal Device is an over-the-counter, home use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. The device includes 12 models, they are M8011, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023. Those models with model name of "M80XX" are equipped with cooling function for a better hair remove experience, while those of "M70XX" have no cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit light pulses.

This FDA 510(k) clearance letter pertains to an IPL Hair Removal Device. The document provided does not detail specific acceptance criteria for a clinical study proving device performance, nor does it describe such a study. Instead, it focuses on non-clinical testing for safety and electrical performance, and a comparison to predicate devices for substantial equivalence.

Therefore, many of the requested sections about clinical study details cannot be answered from the provided text.

Here's a breakdown of the available information:

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

The document does not provide a table of acceptance criteria and reported device performance directly related to hair removal efficacy. The "Performance data" mentioned within the "Comparison of Technological Characteristics With the Predicate Device" section refers to safety and electrical performance to support substantial equivalence, not clinical efficacy.

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

Not applicable. No clinical testing (test set) is described. The non-clinical testing (biocompatibility, electrical safety, etc.) would typically use material samples or test units, not human subjects or "data provenance" in the sense of clinical data.

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

Not applicable. No clinical testing requiring expert ground truth is described.

4. Adjudication method for the test set

Not applicable. No clinical testing with 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-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm; it's a physical device for hair removal.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by validated test methodologies and standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety).

8. The sample size for the training set

Not applicable. No training set is mentioned as there is no AI/machine learning component described for this device.

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

Not applicable. No training set is mentioned.

Summary of what can be extracted from the document regarding "acceptance criteria" and "study":

The document focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than demonstrating efficacy through a dedicated clinical study with specific performance acceptance criteria.

Non-Clinical Testing:

The following non-clinical standards were followed, and presumably, adherence to these standards constitutes the "acceptance criteria" for these specific aspects of the device:

• Biocompatibility:

  • ISO 10993-5: 2009 (Tests for in vitro cytotoxicity)
  • ISO 10993-10: 2021 (Tests for skin sensitization)
  • ISO 10993-23: 2021 (Tests for irritation)
  • Acceptance Criteria (implicit): The device materials must demonstrate non-cytotoxicity, non-sensitization, and non-irritation as per the requirements of these ISO standards.
  • Reported Performance: The document states that differences in materials of patient contact components (compared to the predicate) were "solved by biocompatibility tests," implying the device successfully passed these tests.

• Electrical Safety and Performance:

  • IEC 60601-1:2020 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2020 (Electromagnetic compatibility)
  • IEC 60601-1-11:2020 (Home healthcare environment requirements)
  • IEC 60601-2-83: 2022 (Home light therapy equipment particular requirements)
  • IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
  • IEC 60601-1-6: 2020 (Usability)
  • Acceptance Criteria (implicit): The device must comply with all relevant clauses and performance limits specified in these IEC standards for electrical safety, electromagnetic compatibility, home use, specific light therapy equipment risks, photobiological safety, and usability.
  • Reported Performance: The document provides "performance data were provided in support of the substantial equivalence determination" by listing these standards, indicating successful adherence.

Regarding Clinical Testing:

The document explicitly states: "Clinical Testing: Not applicable." This means no clinical study was conducted, or deemed necessary by the FDA, to demonstrate the device's efficacy for hair removal as part of this 510(k) submission process. Its efficacy is likely presumed based on the established science of IPL technology and the substantial equivalence to already cleared predicate devices for the same intended use.

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IPL Hair Removal Device 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.

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G. The device 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.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0± 0.25cm2 (Model BDE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G) that is suitable for multiple hair removal areas, such as large areas (e.g. arms, legs) and small areas (e.g. bikini line).

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided text is a 510(k) summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices, but it does not contain information regarding detailed acceptance criteria for hair removal efficacy/safety or the study that proves the device meets such criteria.

The document primarily covers non-clinical performance data related to:

1. Biocompatibility Evaluation: Conducted according to ISO 10993-1.
2. Electrical Safety and EMC: Tested against IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-83.
3. Eye Safety: Tested according to IEC 62471.
4. Software Verification and Validation: Documentation consistent with moderate level of concern, demonstrating meeting specifications and mitigating hazards.
5. Usability: Evaluated according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."

The document states that the "IPL Hair Removal Device is 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." However, it does not provide any performance data from a clinical study to demonstrate this claim. It explicitly states that "Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use" but immediately follows this by only listing non-clinical testing.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met, as that specific type of data is not present in the provided text.

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