(244 days)
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The IPL Home Use 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. 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 is by finger switch. The device 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 be triggered a pulse emitting.
The IPL Home Use Hair Removal Device includes D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents and the number of button, lamp cartridge's quantity and appearance; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.
This document is a 510(k) Summary for an IPL Home Use Hair Removal Device. It describes the device, compares it to predicate devices, and outlines the performance data submitted to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests related to safety and general functionality.
However, we can infer the "acceptance criteria" for the tests performed as passing the relevant safety standards.
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization) standards. | "The battery of testing was performed to, and passed." (Implicitly, the device met these standards). |
| Electrical Safety: Meet IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 standards. | "Electrical safety and Eye safety testing was performed to, and passed." (Implicitly, the device met these standards). |
| Eye Safety: Meet IEC 62471 standard. | "Eye safety testing was performed to, and passed." (Implicitly, the device met these standards). |
| Software Verification and Validation: Meet all software requirement specifications and mitigate all software hazards to acceptable risk levels (consistent with moderate level of concern). | "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." |
| Clinical Performance (Inferred from comparison to predicates): Perform hair reduction consistent with the intended use as an over-the-counter device. | "Performance data supports that the device is safe and as effective as the predicate device for its intended use." (This is a general statement, not a specific performance metric). |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a clinical test set for hair removal efficacy. The performance data presented focuses on non-clinical testing (biocompatibility, electrical safety, eye safety, software verification).
- Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of units tested for electrical safety).
- Data Provenance: The document is a 510(k) submission, typically containing test reports from the manufacturer. The location of the manufacturer is Shenzhen, Guangdong, China. The document does not indicate whether the data is retrospective or prospective for any clinical studies, as no clinical studies with human subjects are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided in the document as it focuses on non-clinical engineering and safety aspects, not a clinical study requiring expert assessment of outcomes like hair reduction or disease diagnosis. There is no mention of ground truth establishment by experts for the performance data presented.
4. Adjudication method for the test set
This information is not applicable or provided as there is no human-centric clinical test set requiring adjudication.
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
This information is not applicable. The device is an IPL hair removal device for direct consumer use, not an AI-assisted diagnostic imaging tool that would involve human readers (e.g., radiologists). There is no mention of an MRMC study or AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical IPL hair removal device, not an algorithm. Its operation involves a user directly applying it.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data (biocompatibility, electrical safety, eye safety, software V&V), the "ground truth" is defined by established international and national standards (e.g., ISO 10993, IEC 60601, IEC 62471). The device is tested against these predefined safety and performance criteria.
8. The sample size for the training set
This information is not applicable. As a physical IPL device without an AI component that learns from data, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.