(84 days)
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The subject device IPL Cooling 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 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. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
The provided document is a 510(k) summary for an IPL Cooling Hair Removal Device, which does not typically include information on clinical studies with acceptance criteria as would be found for a diagnostic device. The device is for cosmetic hair removal and its substantial equivalence is based on engineering performance tests and comparison to a predicate device, rather than a clinical effectiveness study with human subjects in the same way an AI-driven diagnostic device might be evaluated.
Therefore, many of the requested categories for a clinical effectiveness study are not applicable or not provided in this document. The device is regulated as a Class II laser surgical instrument for use in general and plastic surgery and in dermatology, but it is indicated for over-the-counter use for unwanted body hair removal.
Here's a breakdown of the information that is available or applicable based on the provided text, and what is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, acceptance criteria are generally based on meeting specified engineering and safety standards, and demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility Safety | ISO 10993-5 (In Vitro Cytotoxicity) | Passed |
| ISO 10993-10 (Irritation and Skin Sensitization) | Passed | |
| Electrical Safety | IEC 60601-1-2 (EMC) | Passed |
| IEC 60601-1 (Basic Safety and Essential Performance) | Passed | |
| IEC 60601-1-11 (Home Healthcare Environment) | Passed | |
| IEC 60601-2-83 (Home Light Therapy Equipment) | Passed | |
| Eye Safety (Photobiological) | IEC 62471 (Photobiological safety of lamps and lamp systems) | Passed |
| Software V&V | Consistent with Moderate Level of Concern, all requirements met, all hazards mitigated (System Validation Testing) | Demonstrated |
| Technological Characteristics | Comparison to predicate device (K221001) in intended use, mode of action, and operational characteristics | Determined to be substantially equivalent with minor differences not affecting safety/efficacy |
| Energy Density Range | Within range of predicate device: 2.0-4.3 J/cm² (predicate) | Subject device: 2.0-4.0 J/cm² (model dependent) |
| Wavelength Range | Compared to predicate device: 530-1100nm (predicate) | Subject device: 550-1100nm or 590-1100nm (model dependent) |
The study that proves the device meets the acceptance criteria is a set of safety and performance tests conducted in accordance with recognized international standards, along with a comparison of technological characteristics to a legally marketed predicate device (K221001).
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Provided. The document describes engineering and safety testing, not a clinical trial with a "test set" of patient data. The tests are performed on the device itself or on components (e.g., biocompatibility on materials).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. This is not a diagnostic device requiring expert consensus for ground truth on medical images or diagnoses. Compliance with standards is typically assessed by testing laboratories and regulatory bodies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. Adjudication methods are relevant for clinical trials or diagnostic accuracy studies, not for device safety and performance testing against engineering standards.
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/Not Provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. This is not an algorithmic device in the context of an AI-driven medical device. Its "software" (for moderate level of concern) would be for device control and safety features, not for standalone diagnostic or analytical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is based on compliance with established international safety and performance standards (e.g., ISO for biocompatibility, IEC for electrical and eye safety), and demonstrating substantial equivalence in technological characteristics and intended use to a legally marketed predicate device. For hair removal effectiveness, the substantial equivalence to an already cleared device implies assumed effectiveness, but no specific effectiveness study data is detailed in this summary.
8. The sample size for the training set
- Not Applicable/Not Provided. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. As there is no training set mentioned, this question is not applicable.
§ 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.