(195 days)
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
The CLARO is a portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp. The device is powered by a rechargeable battery. CLARO is intended to be a prescription device which will be used both in the doctor's office and in the home environment for the treamment of mild to moderate acne.
The provided text, a 510(k) summary for the CLARO device, does not contain specific acceptance criteria or details of a study proving the device meets particular performance metrics.
Instead, it states:
"Performance testing will be performed which will demonstrate compliance with IEC 60601-1-1 and IEC 60601-1-2. Testing was submitted which showed that the user was able to use the device in the home-use environment."
This indicates that general safety and essential performance standards (IEC 60601-1-1 and -1-2) would be addressed, and a user study demonstrated home-use feasibility. However, no specific performance criteria related to acne treatment efficacy, clinical outcomes, or comparative performance are detailed, nor are the results of any such study presented in this document.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission and substantial equivalence to predicate devices, not on detailed performance study results against specific acceptance criteria for efficacy.
§ 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.