(88 days)
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
The Light based 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 IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.
This document, K180383, is a 510(k) summary for the "Light based hair removal device" by Shenzhen GSD Tech Co., Ltd. It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA approval.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for efficacy or hair reduction. The core of the submission is to demonstrate that the new device is as safe and effective as previously cleared devices.
The "acceptance criteria" in this context are interpreted as compliance with relevant regulatory standards and demonstrating similar technological and performance characteristics to the predicate device, implying similar safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) and not a study with specific efficacy endpoints, there isn't a direct "acceptance criteria" table in terms of clinical performance metrics (e.g., % hair reduction). Instead, the performance shown is in relation to safety and regulatory compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993 standards for body-contacting parts | Passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization) |
| Electrical Safety: Comply with relevant IEC 60601 standards | Passed IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 |
| Eye Safety: Comply with relevant IEC standard | Passed IEC 62471 (Photobiological safety) |
| Software Validation: Meet software requirements for moderate level of concern | System validation testing demonstrated all software requirement specifications met and hazards mitigated |
| Technological Characteristics: Similar to predicate devices | Detailed comparison in Section VI showing similar intended use, energy medium, pulsing control, and mechanism of action. Differences in pulse duration, energy density, and spot size deemed not to raise safety/efficacy concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- No human clinical study data is presented for efficacy. The studies described are engineering/laboratory tests (biocompatibility, electrical safety, eye safety, software validation).
- Therefore, there is no "test set" in the context of human subjects, nor data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As no human clinical efficacy study is described, there is no "ground truth" established by experts in that context. The "ground truth" for the engineering tests would be the established international standards themselves, and the expertise lies with the testing laboratories performing the assessments.
4. Adjudication Method for the Test Set
- Not applicable. There is no human clinical test set requiring adjudication in the document.
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 light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was done or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device in the sense of AI. The software validation is for the device's operational software, not for an AI algorithm.
7. The Type of Ground Truth Used
- For the engineering tests, the "ground truth" is the established and recognized international standards (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). Compliance with these standards indicates safety and performance.
8. The Sample Size for the Training Set
- Not applicable. There is no machine learning or AI component mentioned that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
In summary:
This 510(k) submission demonstrates the substantial equivalence of the "Light based hair removal device" by showing that it meets recognized safety and performance standards through engineering and biocompatibility testing, and that its technological characteristics are similar to those of predicate devices. It does not include clinical efficacy studies with human subjects or AI performance evaluations.
§ 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.