(52 days)
The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.
The IPL Hair Removal is a personal. light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. 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. The device mainly contains a Xenon lamp and a skin 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 pulses. The device is for single-person use only. For model SL-B287 and SL-B329, they consist of IPL beauty device main body and power adapter (12V3A) two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglass. The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device, select light intensity level), Flash button (to start flashing) and loe Cooling button (to select ice cooling mode and switch manual / auto flash mode). For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglass and replacement lampshade. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.
The provided text is a 510(k) summary for an IPL Hair Removal device. It mostly focuses on comparing the subject device to predicate devices for substantial equivalence and outlining non-clinical tests conducted. Unfortunately, it explicitly states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, I cannot provide information on acceptance criteria based on clinical studies, device performance from such studies, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or training set details as this information is not present in the given document.
The document only details non-clinical tests for electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation.
Here's the information that can be extracted based on the provided text regarding non-clinical tests:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment: General requirements for basic safety and essential performance) | Complied |
| IEC 60601-1-11 (Medical Electrical Equipment: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment) | Complied |
| IEC 60601-2-57 (Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) | Complied |
| IEC 60601-1-2 (Medical electrical equipment: Electromagnetic disturbances - Requirements and tests) | Complied |
| IEC 62471 (Photobiological safety of lamps and lamp systems) | Complied |
| ISO 10993-5 (Biocompatibility: Cytotoxicity) | Complied |
| ISO 10993-10 (Biocompatibility: Sensitization and Skin Irritation) | Complied |
| Software Verification and Validation (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | Conducted and documentation provided |
| Usability Testing (IEC 62366-1 and IEC 60601-1-6) | Conducted |
2. Sample size used for the test set and the data provenance:
- Not applicable for clinical studies. The document mentions non-clinical tests, for which "test sets" in the context of clinical data/patients are not relevant. Details about the specific samples (e.g., number of units tested) for electrical, EMC, and biocompatibility tests are not provided.
- Data Provenance: Not applicable as no clinical data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical data or expert evaluations for ground truth establishment are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical data or adjudication for a test set is mentioned.
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. The device is an IPL Hair Removal device, not an AI-assisted diagnostic or interpretative tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical IPL hair removal device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" is typically defined by the standards themselves, and compliance is assessed against the requirements of those standards.
8. The sample size for the training set:
- Not applicable. No clinical data or machine learning model requiring a training set is mentioned for the device. The software mentioned is for device control, not for data analysis or interpretation with AI.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model 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.