(213 days)
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair. It utilizes a diode LED as a light source (780-850 nm). lt 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 emission activation is by finger switch.
The device contains a capacitive 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 emit the treatment light. The device is for single-person use only.
The proposed Planar LED mate is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
The device has 5 level Output Intensity.
This submission for the Planar LED mate (K230362) does not include a study that proves the device meets specific acceptance criteria related to its performance for hair removal. Instead, it relies on non-clinical tests to demonstrate substantial equivalence to predicate devices and adherence to safety and performance standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for hair removal efficacy and corresponding device performance. The focus is on demonstrating that the device's technical characteristics and safety comply with relevant standards and are similar to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated for hair removal efficacy) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity | No Cytotoxicity |
| No evidence of sensitization | No evidence of sensitization | |
| No evidence of irritation | No evidence of irritation | |
| Electrical Safety | Comply with ANSI/AAMI ES60601-1, IEC 60601-1-11 | Comply with ANSI/AAMI ES60601-1, IEC 60601-1-11 |
| Electromagnetic Compatibility (EMC) | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-83, IEC 62471 | Comply with IEC 60601-2-83, IEC 62471 |
| Software Verification & Validation | Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Software Verification and Validation Testing was conducted per guidance. |
| Usability & Label Comprehension | Usability and label comprehension evaluated | Usability and label comprehension study conducted. |
| Energy Output | Accuracy of energy output (Specific numerical criteria not provided) | Performance Testing for Energy Output Accuracy conducted. |
| Hair Removal Efficacy | Not explicitly stated in terms of quantitative criteria or success rates. | The submission does not include clinical study results to demonstrate specific hair removal efficacy. It states the device is intended for "removal of unwanted body and/or facial hair" based on the theory of selective photothermolysis, similar to predicate devices. |
2. Sample size used for the test set and the data provenance
- For hair removal efficacy: Not applicable. No clinical test set involving human subjects for hair removal efficacy was conducted or reported in this submission.
- For non-clinical tests (biocompatibility, electrical safety, EMC, laser safety, software, usability, energy output): The document does not specify the sample sizes for these tests (e.g., number of units tested, number of participants in usability study). The tests were likely performed in a laboratory setting, but the provenance of the data itself (e.g., from which specific test labs) is not detailed beyond adherence to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for hair removal efficacy. As no clinical study was performed, there was no ground truth for this purpose established by medical experts for a test set.
- For non-clinical safety and performance: Ground truth for these aspects is generally established by adherence to recognized international standards (e.g., ISO, IEC, ANSI/AAMI) for testing methodologies and acceptable limits, rather than by individual expert consensus on a test set. The experts involved would be those who performed the standard-compliant testing and validated the results. Their specific qualifications are not detailed in this summary.
4. Adjudication method for the test set
- Not applicable for hair removal efficacy. No clinical test set was performed.
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 hair removal system, not an AI-assisted diagnostic or therapeutic imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware-based light energy device for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For hair removal efficacy: Not applicable. No clinical study was performed, so no "ground truth" for efficacy (e.g., based on clinical outcomes or hair counts) was established.
- For device safety and technical performance: The "ground truth" is based on established engineering and biocompatibility standards (e.g., IEC 60601-1, ISO 10993, IEC 62471) which define acceptable limits and performance criteria for medical devices. Compliance with these standards serves as the benchmark.
8. The sample size for the training set
- Not applicable. This device is a hair removal system and does not appear to involve machine learning algorithms that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. As no training set is mentioned, this question is not relevant.
In summary: The provided 510(k) summary for the Planar LED mate (K230362) focuses on demonstrating substantial equivalence through a comparison of technological characteristics with predicate devices and comprehensive non-clinical testing against established safety and performance standards. Crucially, it explicitly states, "No clinical study is included in this submission," meaning there is no direct clinical data or study to demonstrate the device's hair removal efficacy against specific acceptance criteria.
§ 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.