(90 days)
Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. The device 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 Hand-held Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm² (Model BFZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) that is suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen.
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. Besides, the Hand-held Hair Removal Device has the cooling function (suitable for model CT05, CT06, CT07, CT08, CT09), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
The provided 510(k) summary for the "Hand-held Hair Removal Device" does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to hair removal efficacy.
The document focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and compliance with various safety and regulatory standards.
Here's a breakdown of why I cannot fulfill your request for acceptance criteria and a study proving device performance based on the provided text, and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Available: The document does not list any quantitative acceptance criteria for hair reduction or removal efficacy. It also does not report any device performance metrics related to hair removal (e.g., percentage of hair reduction after a certain number of treatments, hair count at 6, 9, or 12 months).
- What is available: The document states the "Indications for Use" which defines "permanent reduction in hair regrowth" as a "long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime." However, it doesn't provide data to show if or how much reduction was achieved by this specific device.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Available: There is no mention of a clinical test set used to evaluate the device's hair removal efficacy. Therefore, sample size and data provenance are not reported.
- What is available: The document lists various safety and electrical performance tests (Biocompatibility Evaluation, Electrical Safety and EMC, Eye Safety, Software Verification and Validation, Usability), but these are not for efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Available: Since no clinical efficacy study is described, there is no mention of experts establishing ground truth for efficacy.
4. Adjudication Method for the Test Set:
- Not Available: Not applicable as no clinical efficacy study is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Available: This type of study is not mentioned. The document focuses on demonstrating equivalence to predicate devices, not on comparing performance with or without AI assistance for human readers (which is relevant for diagnostic devices, not typically for hair removal devices).
6. Standalone Performance Study:
- Not Available: While the document mentions "Performance Data," it refers to non-clinical tests (biocompatibility, electrical safety, eye safety, software, usability). There is no standalone clinical performance study data presented for the actual hair removal efficacy of the device.
7. Type of Ground Truth Used:
- Not Available: As no clinical efficacy study is described, no ground truth for hair removal efficacy is mentioned.
8. Sample Size for the Training Set:
- Not Available: Since there's no mention of a machine learning or AI component for efficacy (only general "Software Verification and Validation"), there is no "training set" in the context you're asking about (i.e., for learning to perform hair removal or analyze its results).
9. How Ground Truth for the Training Set Was Established:
- Not Available: Not applicable, as no such training set is mentioned.
In summary:
The 510(k) summary provided indicates that the "Hand-held Hair Removal Device" is being cleared based on its substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and compliance with general safety and electrical standards. It does not present specific clinical performance data, acceptance criteria for efficacy, or studies demonstrating the device's hair removal performance. The emphasis is on showing that it is as safe and effective as previously cleared devices based on similarity and non-clinical testing, rather than providing novel clinical trial data for its hair reduction capabilities.
§ 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.