(170 days)
The Home Use IPL Beauty 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.
The Home Use IPL Beauty 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. Of which, the Device includes MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6 and MELSYA-M7 six models. All have adopted the same structure design, 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. Meanwhile, the device is power from power adapter via an external power.
The difference of all models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of model MS-208B, MS212B and MELSYA-M6 is designed to 3.6cm², model MS-216B, MS-218B and MELSYA-M7 is designed to 3.0 cm2, as well as the energy density of the all models is in the range of 2.0~5.1J/cm².
The provided document is a 510(k) premarket notification for a "Home Use IPL Beauty Device" for hair removal. It does not include information about clinical studies with detailed acceptance criteria, sample sizes, expert involvement, or adjudication methods for proving the device meets acceptance criteria related to its efficacy in hair removal.
Instead, the performance data provided focuses on:
- Biocompatibility Testing: Ensuring the device materials are safe for body contact.
- Electrical Safety and Eye Safety: Compliance with relevant international standards for medical electrical equipment and photobiological safety.
- Software Verification and Validation: Ensuring the software operates as intended and mitigates hazards.
The document states, "The Home Use IPL Beauty Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use." This implies that substantial equivalence is primarily established through comparison to predicate devices and demonstrating compliance with safety and electrical standards, rather than new clinical hair removal efficacy studies with specific performance metrics for the subject device.
Therefore, I cannot extract the specific information requested regarding acceptance criteria and a study proving those criteria for hair removal efficacy from this document. The information you are asking for typically comes from a clinical validation study demonstrating the device's effectiveness, which is not detailed in this 510(k) summary.
§ 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.