(55 days)
The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
The Precise Touch Pro Home use hair removal 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 Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body, AC adapter and device stand three parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria related to medical effectiveness (e.g., hair reduction efficacy percentages).
The document is a 510(k) summary for a home-use hair removal device (Precise Touch Pro) and focuses on demonstrating substantial equivalence to predicate devices, not on proving de novo clinical efficacy against specific acceptance criteria.
The "Performance Data" section primarily addresses:
- Biocompatibility Testing: Ensuring the materials are safe for body contact.
- Electrical Safety and Eye Safety: Compliance with relevant international standards.
- Software Verification and Validation: Assuring software functions correctly and mitigates risks.
These are safety and engineering performance aspects for regulatory compliance, not efficacy performance related to the device's intended use of hair removal in terms of, for example, a targeted percentage reduction in hair.
Therefore, I cannot provide the requested information regarding acceptance criteria for device performance and a study proving it, as that information is not present in the provided text.
§ 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.