(61 days)
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:
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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.
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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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.