(59 days)
The product is an over-the-counter device intended for removal of unwanted body and facial hair.
IPL hair removal device 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 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 contains a Xenon lamp and a skin tone 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 hair removal device includes LS101 and LS102 two models. Their intended use, performance, structure design and operation are identical, with the different color of grip part. The difference does not affect or change the intended use of the device.
The provided document is a 510(k) Premarket Notification for an IPL hair removal device. It focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and safety standards, rather than clinical performance or AI/software-based diagnostics. Therefore, much of the information requested, particularly regarding acceptance criteria for diagnostic performance, AI study details, expert review, and ground truth establishment in a medical imaging context, is not present in this document.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define explicit "acceptance criteria" in the sense of a clinical trial or AI model performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices by confirming the subject device meets the same safety and performance standards.
The table below summarizes the comparison elements used to demonstrate substantial equivalence, which implicitly act as performance criteria for the device's technical specifications. The "Reported Device Performance" column reflects the subject device's specifications.
| Elements of Comparison (Implicit Acceptance Criteria) | Reported Device Performance (Subject Device: IPL hair removal device, Model: LS101, LS102) | Predicate Device 1: iPulse SmoothSkin Gold Hair Removal Device | Predicate Device 2: PerfectSmooth | Remarks (from document) |
|---|---|---|---|---|
| Indications for Use | Removal of unwanted body and facial hair (OTC) | Removal of unwanted hair (OTC) | Removal of unwanted hair (OTC), e.g., underarm, facial hair below chin, legs. | SE (Substantially Equivalent). Different wording, but similar actual use. |
| Wavelength range | 523nm ~ 1100nm | 510-1100nm | ≥510nm | SE. Both comply with IEC 60601-1, IEC 60601-2-57. |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE |
| Energy density | 3.2-6.5J/cm² | 3-6J/cm² | 4.7 J/cm² | SE. Complies with IEC 60601-1, IEC 60601-2-57. Subject device range overlaps with Predicate 1. |
| Spot size | Standard care head: 3cm² (30mm*10mm) | |||
| Precision care head: 1.2cm² (12mm*10mm) | 3cm² (3cm by 1cm) | 4.5 cm² | SE. Both comply with IEC 60601-1, IEC 60601-2-57. | |
| Pulse duration |
§ 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.