(66 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 IPL technology. 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.
The IPL Hair Removal includes SL-B080, SL-B126, and SL-B136 three models. The difference of all models is mainly the exception of appearance and number of buttons which do not affect the intended use. For model SL-B080, it consists of an IPL beauty device main body and power adapter 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, sunglasses and replacement lampshade in addition to the IPL beauty device main body and adapter. 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.
For model SL-B126 and SL-B136, consisting of IPL beauty device main body and power adapter 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 sunglasses in addition to the IPL beauty device main body and adapter.
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), Auto/Manual button and Flash button.
The provided text describes a 510(k) premarket notification for an IPL Hair Removal device (models SL-B080, SL-B126, SL-B136). The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical performance studies, is largely not present in this regulatory document.
However, based on the provided text, I can extract and infer some information related to safety and performance testing that serves as a form of acceptance criteria for regulatory clearance.
1. Table of Acceptance Criteria (Based on Compliance with Standards) and Reported Device Performance
| Acceptance Criteria (Based on Compliance with Standards) | Reported Device Performance |
|---|---|
| Biocompatibility: Device components in body contact must meet ISO 10993 standards. | Complied with: |
- ISO 10993-5:2009/(R)2014 (Tests for In Vitro Cytotoxicity)
- ISO 10993-10:2010/(R)2014 (Tests for Irritation and Skin Sensitization) |
| Electrical Safety: Device must meet general and collateral safety standards for medical electrical equipment. | Complied with: - IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1 (Basic safety and essential performance)
- IEC 60601-1-11 (Medical Electrical Systems Used in the Home Healthcare Environment)
- IEC 60601-2-57 (Non-laser source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) |
| Eye Safety: Device must meet photobiological safety standards. | Complied with: - IEC 62471 (Photobiological safety of lamps and lamp systems)
- IEC 60601-2-57 (re-emphasized for non-laser source equipment) |
| Usability: Device must meet standards for usability in medical electrical equipment. | Complied with: - IEC 60601-1-6 (Usability) |
| Software Verification and Validation: Software must meet specified requirements and mitigate hazards. | Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and hazards mitigated. |
| Performance Equivalence: Device performance characteristics (wavelength, pulse duration, energy density, spot size) should be comparable to predicate devices. | Wavelength Range: 510-1100nm (Same as Predicate 1, Predicate 2 not publicly available)
Pulse duration: 9-12 milliseconds (Similar to Predicates 1 & 2)
Energy density: 2.2-4.0J/cm² (Similar to Predicates 1 & 2, noted as not raising new safety/effectiveness issues)
Spot size: 3.0cm² (Same/similar to Predicates 1 & 2) |
2. Sample size used for the test set and the data provenance
The document does not detail specific human subject test sets or their sample sizes for proving the device's efficacy in hair removal. The "Test Summary" primarily refers to lab bench testing for biocompatibility, electrical safety, eye safety, and software verification/validation, which do not typically involve human subjects or data provenance in the clinical sense. These tests are performed in a laboratory setting on the device itself or on materials representative of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are laboratory-based compliance tests against international standards, not clinical studies requiring expert-established ground truth for specific clinical outcomes.
4. Adjudication method for the test set
Not applicable. The tests described are laboratory-based compliance tests, not clinical studies that would typically involve adjudication of results by multiple human readers.
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 an IPL hair removal device, not an AI-powered diagnostic tool, and the submission does not involve an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, and the submission does not describe standalone algorithm performance.
7. The type of ground truth used
The "ground truth" in this context is the international and recognized consensus standards (e.g., ISO, IEC) for safety and performance. The device is deemed safe and effective if it successfully passes these predefined tests.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set. The tests performed are for device safety and performance, not for training a model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device and submission.
§ 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.