(88 days)
IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
The IPL Hair removal is a personal, light-based, hair reduction device intended to be sold overthe-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The device consists of IPL main body and power adapter two parts, and treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is power from power adapter via an external power.
The IPL Hair removal includes V501, V201, V301-s, and V401 four models. Their intended use, performance, circuit principle, structure design and operation are basically identical, with the differences contains the appearance of the product , the size of PCB board and LCD display contents; and these differences do not affect or change the intended use of the device.
This document is a 510(k) premarket notification for an "IPL Hair removal" device. It demonstrates substantial equivalence to existing predicate devices, focusing on technical specifications and safety testing, rather than clinical performance data typical for AI/ML-based diagnostic devices.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this submission, as it is a device for hair removal and not an AI or diagnostic tool. The document focuses on showing the new device is as safe and effective as previously cleared over-the-counter IPL hair removal devices.
Here's an attempt to address the points based on the provided document, with clear indications of where information is not applicable (N/A) due to the nature of the device and submission:
Device: IPL Hair Removal (Models V501, V201, V301-s, V401)
Type of Submission: 510(k) Premarket Notification (K203510)
Device Classification: Class II, Product Code OHT (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology)
Intended Use: Over-the-counter device intended for removal of unwanted body hair and/or facial hair.
1. A table of acceptance criteria and the reported device performance
For this type of device, "acceptance criteria" are primarily related to safety and technical specifications, demonstrating substantial equivalence to predicate devices, rather than performance metrics like sensitivity/specificity for a diagnostic AI. The document outlines comparisons to predicate devices in terms of technical characteristics and adherence to safety standards.
| Acceptance Criteria (General) | Reported Device Performance (as per document) |
|---|---|
| Functional Equivalence to Predicate Devices | "The IPL Hair removal has the same intended use, mode of action and similar operational characteristics as the predicate devices." (Page 4, Section VI) |
| Safety - Biocompatibility | Passed ISO 10993-5:2009/(R)2014 (In Vitro Cytotoxicity) and ISO 10993-10:2010/(R)2014 (Irritation and Skin Sensitization) for body-contacting components. (Page 6, Section 1) |
| Safety - Electrical & Eye Safety | Passed IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1 (General Safety), IEC 60601-1-11 (Home Healthcare Environment), IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use), and IEC 62471 (Photobiological safety). (Page 6, Sections 2 & 3) |
| Software Verification & Validation | Software documentation consistent with moderate level of concern was submitted. System validation testing "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." (Page 6, Section 4) |
| Performance (general) | "Performance data supports that the device is safe and as effective as the predicate device for its intended use." (Page 4, Section VI) This is a summary statement, not specific quantitative performance data for hair removal efficacy itself (e.g., percentage of hair reduction over time), which is commonly accepted for OTC hair removal devices via comparison to predicates. The document implies that the device's technical specifications (wavelength, energy density, spot size, pulse duration) are comparable enough to the predicates to infer similar performance. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For biocompatibility, electrical safety, and eye safety, the "samples" are the device components or the device itself undergoing standard tests. The document doesn't specify a "sample size" in terms of human subjects or a dataset for performance evaluation in the way an AI/diagnostic device would.
- No clinical "test set" in the context of diagnostic accuracy for AI devices is mentioned or required for this type of 510(k) submission.
- Data Provenance: N/A for a clinical test set. The data presented is from in-house engineering and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This information is not relevant to this 510(k) submission. This device is not an AI/diagnostic tool requiring expert-established ground truth for performance evaluation. Safety and technical compliance are assessed against established standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical test set requiring adjudication of ground truth is 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
- N/A. This device is an over-the-counter physical hair removal device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. Not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No diagnostic "ground truth" is used for this device. The "truth" for this submission is adherence to recognized safety standards and functional equivalence to legally marketed predicate devices.
8. The sample size for the training set
- N/A. This device does not use a "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established
- N/A. Not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria (based on provided document):
The "study" proving the device meets acceptance criteria for this 510(k) submission is a compilation of engineering tests and comparative analysis rather than a clinical trial or AI performance study:
- Technical Comparison: The applicant demonstrated that the
IPL Hair removaldevice has the "same intended use, mode of action and similar operational characteristics" as its identified predicate devices (K192432, K161428, K160968). This includes comparing wavelength range, energy medium, energy density, spot size, pulse duration, pulsing control, delivery device, and indications for use. - Biocompatibility Testing: Body-contacting components were tested and passed ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization).
- Electrical Safety and Eye Safety Testing: The device was tested against and passed several IEC 60601 series standards for electrical safety, essential performance, and electromagnetic compatibility in both general and home healthcare environments, as well as IEC 62471 for photobiological safety.
- Software Verification and Validation: Software documentation meeting "moderate level of concern" was submitted, confirming that software requirements were met and hazards mitigated.
The conclusion is that, based on these performance data, the IPL Hair removal device "was found to have a safety and effectiveness profile that is similar to the predicate devices," thereby establishing substantial equivalence.
§ 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.