(62 days)
Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Intense pulsed light therapy apparatus 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, reducing hair growth with minimal pain.
The device includes 12 model: FDA01, FDA02, FDA03, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an "S" indicates that the model has a 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 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.
The provided FDA 510(k) Summary for the "Intense pulsed light therapy apparatus" describes the device's technical characteristics and how it compares to predicate devices to establish substantial equivalence. However, it does not present acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to its efficacy (e.g., hair removal effectiveness) in the format of a clinical study with a test set, ground truth, expert adjudication, or MRMC studies.
The "Performance Data" section primarily focuses on non-clinical performance data (biocompatibility, electrical safety, EMC, eye safety, software V&V, and usability testing), which are crucial for safety but do not assess the primary clinical function (hair removal efficacy).
Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and a study proving clinical efficacy, as that type of study is not detailed in this document.
However, I can extract and state what is provided regarding the safety and non-clinical performance, and explicitly mention what is missing per your request.
Based on the provided K241120 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to predicate devices through similar technological characteristics and adherence to safety standards, rather than proving performance against specific quantitative clinical acceptance criteria for hair removal efficacy.
| Area of Performance | Acceptance Criteria (Implicit from Standards/Comparison) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets ISO 10993-5, ISO 10993-10, ISO 10993-23 for in vitro cytotoxicity, skin sensitization, and irritation. | Passed all specified ISO 10993 tests. |
| Electrical Safety & EMC | Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-11, IEC 60601-2-83 standards. | Passed all specified IEC 60601 electrical safety and EMC tests. |
| Eye Safety | Meets IEC 62471 standard for photobiological safety. | Met IEC 62471. |
| Software Verification & Validation | All software requirement specifications are met and all software hazards mitigated to acceptable risk levels (consistent with moderate level of concern). | System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated. |
| Usability | Evaluated according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | Evaluation performed as per FDA guidance. |
| Technological Characteristics (for Substantial Equivalence) | Similar intended use, wavelength range, energy density, spot size, pulse duration, and safety features to predicate devices. | Wavelength range (510-1200nm), energy density (1.2-3.5 J/cm²), spot size (3.0 cm²), and pulse duration (3.5-4.5ms) were found to be "similar" to predicate and reference devices, with "minor differences" not raising safety/efficacy issues. |
2. Sample size used for the test set and the data provenance:
- Clinical Efficacy Test Set: Not mentioned or detailed. The document primarily focuses on non-clinical/safety testing and comparison to predicates.
- Safety Testing (e.g., Biocompatibility, Electrical Safety): These involve laboratory sample sizes specific to the tests (e.g., cell cultures, test circuits), not human subjects for efficacy. Data provenance is implied to be from laboratory testing conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Clinical Efficacy: Not applicable, as a clinical efficacy study with human subjects requiring ground truth establishment is not described in the provided text.
- For Safety/Technical Data: The "experts" would be the engineers, toxicologists, and quality control personnel performing the specified lab tests and evaluations. Their qualifications are implicit in their ability to perform and interpret these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For Clinical Efficacy: Not applicable, as a clinical efficacy study is not 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 apparatus, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to its stated function or the type of data presented in this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device for treatment, not a standalone algorithm.
7. The type of ground truth used:
- For Clinical Efficacy: Not applicable, as a clinical efficacy study is not described.
- For Safety/Non-Clinical Data: Ground truth is established by regulatory standards and established laboratory test methods (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). Passing these tests constitutes meeting the safety "ground truth."
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its software components are primarily for device control, safety interlocks, and user interface, verified via standard software V&V methods rather than machine learning training.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is mentioned.
§ 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.